CN104507416B - Cardiac valve support structure - Google Patents

Abstract

The invention mainly relates to heart valve support part, it is suitable to endovascular and is put into cardiac valve, including the first and second support components and at least two bridge member that extends to the second support component from the first support component.Valve support may further include extra element, its objective is to improve in heart valve annulus region, especially mitral valve ring, the stability of device after implantation.

Description

Cardiac valve support structure

Technical field

The present invention relates to the various improvement to cardiac valve support structure, described cardiac valve support structure includes by two Two support components that individual or multiple bridge members interconnect.

Background technology

Cardiac valve adverse current heart lobule when heart contraction occurs when not being fully closed.When heart contraction, blood To the dynamic lobule by incorrect Guan Bi of backflow.Such as, dynamic by Bicuspid valve and entrance to backflow at blood when ventricular systole Mitral regurgitation is there is during left atrium.

Under certain situation, there is (such as master or " organic " are countercurrently) in adverse current due to valve leaflet disease.Adverse current is also led to Crossing the expansion of left ventricle and cause, this can cause the compound expansion of mitral valve ring.The expansion of valve annulus makes leaflet of mitral valve Extension separately and forms very poor most advanced and sophisticated by-election (tip cooptation) and secondary leakage, or so-called " functional regurgitation ".

At present, main adverse current is reinvented primary lobule by trial and is revised, such as by clip, stitching, hook etc., to permit Permitted them fully to close when heart contraction.When disease development is too fast, whole lobe need by machinery or the vacation of biology Body is changed.Example includes that the actual valve that valve forming ring is sewn onto band lobule always changes part, and wherein suture ring is sewn To mitral valve ring.Valve forming ring is also stitched into valve annulus, and valve forming ring is also used for reinventing valve annulus so that primary Lobule is close together, to allow them correctly to close.

The success changed based on aortic valve, constantly receives publicity, assesses similar technology and non-invasively use phase Replacing valve replacing Bicuspid valve like type.

But, it being different from aortic valve, mitral valve ring does not provide the labelling changing valve for good location.At needs In the patient of aortic valve, the height of aortic valve ring and width generally form relevant degenerative disease existing to calcium In the case of and increase.The cross-sectional area reduced due to aortic valve ring, these changes in tissue make it easier to correct Fix the aortic valve of replacing.But, the degenerative change generally found in aortic valve is not present in experiencing inverse In the mitral valve of stream, and mitral valve ring is therefore thinner than the valve annulus of ill aortic valve.Thinner Bicuspid valve Film ring makes its cardiac valve (replacement being relatively difficult to correctly position replacing in primary mitral valve ring heart valve).It is fixing just that the general anatomical structure of mitral valve ring also makes it be difficult to the correct cardiac valve by replacing Position.The ratio of the transitional face from aorta to left ventricle provided with aortic valve ring, mitral valve ring is for from left atrium to a left side The transition that ventricle is smoother.Aortic valve ring is the most notable, it is provided that bigger " projection ", the aortic valve of replacing is more The most in position to described " projection ".

Generally, aortic valve chain rate mitral valve ring is less.The estimated about 2.4cm of mitral valve ring is to about The diameter of 3.2cm, and the diameter of aortic valve ring estimated about 1.6cm to about 2.5cm.

Bigger mitral valve ring makes it be difficult in primary two point positions and implants the valve that current percutaneous is put securely. The current aortic valve changed can be restricted in terms of the expansion of experience and amount of radial expansion during they are implanted.In order to carry The aortic valve of the replacing in mitral valve ring can be securely fixed in, it would be desirable to this replacing for having expanded configuration Aortic valve contraction put profile increase.But, increase to shrink and put profile endovascular will be made to be rivals in a contest for patient More dangerous, and to be guided in vascular system by bigger diameter delivery system be more difficult.

Make some to attempt putting and implant single-piece replacing Bicuspid valve, can accept it can be difficult to provide and have There is sufficiently small storing profile and still can expand in Bicuspid valve and device in position via blood vessel intervention position.

Needing a kind of valve support structure or fixing device, it can be positioned in primary Bicuspid valve or neighbouring and be suitable to more The cardiac valve changed is in position.

Summary of the invention

One aspect of the present invention is heart valve support part, and it is suitable to endovascular and is put into cardiac valve, including: first Support component, has contraction and puts structure and deployment configuration；Second support component, has contraction and puts structure and deployment configuration； At least two bridge member extends to the second support component from the first support component, and each of which bridge member has storing structure Make and deployment configuration；Wherein under deployment configuration, described bridge member extends radially inwardly from the first and second support components.

In another preferred embodiment of the heart valve support part of the present invention, described support member includes first and second Support element, each of which has contraction and puts structure and deployment configuration；

And at least two of which bridge member extends to the second support component from the first support component, described bridge member has Have storing structure and deployment configuration, wherein launch under described bridge member longitudinal extension, and the first and second support components it Between there is no any appreciable radial buckling.

Phrase " does not has any appreciable radial buckling " it will be appreciated that in the present case, refers to without auxiliary Help the un-flexed so that bridgeware during eye-observation is the most straight.

The periphery of at least one in the particular preferred embodiment of above-mentioned heart valve support part, in two support components While be perfect rigidity, thus under its deployment configuration, it is impossible to cause the outer dia of the one or more support component Further expansion.

And then, in some particular preferred embodiments of the present invention, the inner rim of one or two support component can be along footpath It is resiliently deformed to direction.It will be understood, therefore, that the deformable support component of the cyclic spring of the present invention has outer dia and interior Portion's diameter.In use, the valve support element of the present invention is chosen to, under the deployment configuration that it is fully expanded, more The outer dia that the cardiac valve changed has is more bigger than the inside diameter of support component (when it is expanded).Subsequently, prop up at valve When the valve of replacing is put in the inner space of support element, due to one or two support component elastically deformable, one The inside diameter of individual support component increases.The valve changed is securely held in valve support from there through radially inner power In part in place, described power is applied on described valve by the resiliency deformable portion of one or two support component, and this is institute State the elastic inner surface of support component (one or more) and return what the trend of its rest position was caused.

It should be noted that the support component of elastically deformable can be configured such that, or its whole inner surface elastically deformable, Or alternatively, it can be configured such that only some of discontinuous region elastically deformable.

Although the heart valve support part of the present invention can include two or more bridge member, but preferred at one In embodiment, described valve support is equipped with only two bridge members.

In certain embodiments, the first and second bridge members are from around the first and second of the first and second support components Discontinuous position extends, and can extend symmetrically from the first and second support components.First and second bridge members are from first Relative to each other can be with about 180 degree of extensions with the second support component.

In some other embodiments, valve support device can farther include southbridge component alternatively and (sometimes exist Hereinafter referred to as " bridgeware "), two or more main bridge members are interconnected by it.In other embodiments, southbridge component is used for One or more main bridge members are connected with support component.Term " southbridge component " is herein for by described optional volume Outer bridgeware distinguishes with the main bridge member being connected the first and second support components, as above-described.

In a preferred embodiment, at least one in the first and second support components has annular shape.

The contour shape that annular brace element has can be circle, oval or allow it to be suitable to be implanted to heart valve Close any other form contacted with internal cardiac wall time in the region of film ring.

In a radial plane (the most primary heart valve leaflets plane at place when make position at which), at least one The size of support component (latter two element of storing above that) can be with its outer radius (Ro), its inner radial (Ri) With the difference (Rd) between the two radius limits.Should be understood that Ro passes through will the mitral valve of implanted valve support device The diameter of ring determines.But, Ri is by by valvular for the replacing in the central space being inserted into support means outer dia Determine.Generally, the prosthetic aortic valve's film being used in combination with the valve support device of the present invention has obtain less than mitral valve ring Many outer dias.Thus, generally, the scope of the outer dia of support component substantially 30-50mm, and its inside diameter is substantially Scope for 23-29mm.Thus, it will be appreciated that Rd is approximately corresponding to two points changing valve and relatively large diameter of little outer dia Annular gap between valve annulus.Thus, in a preferred embodiment, at least one support component is under its deployment configuration The form of annular ring, the difference between outer radius and the inner radial of wherein said annular ring is in the range of 1-20mm.For The thickness (t) (in position along the longitudinal axis measurement of element time (in situ)) of support component, t represents and makes this parameter minimum Change to contribute to curling and the needs that are inserted in deployment catheter and making support means sufficiently rigid thus it can be resisted and beat The power that applies of heart and balance between non-sticking needs.One typical nonrestrictive example is that t is 0.4mm, and Rd has the value of 5.5mm.It practice, as common rule, in most of embodiment of the annular brace element of the present invention, Rd is more much bigger than t.Such as, in many cases Rd can than t big 2.5 to 35 times, more preferably than t big 10 to 20 times.In the past The ratio stated between the bright Rd of being appreciated that and t has meaning functionally to the valve support device of the present invention.

As it has been described above, in a preferred embodiment of the invention, valve support device is used for assisting prosthetic aortic valve's film to plant Enter in the mitral valve ring of the human body needing this implantation.The thickness of at least one in two support components is usually The scope of 0.25-0.6mm, more preferably 0.4mm.

In certain embodiments, bridge member and/or support component are equipped with the heart valve being suitable to be securely engaged replacing The replacing valve bonded device of film.It should be noted that term " valve bonded device " can be mutual with term " valve attachment means " at this paper Use with changing.In certain embodiments, bonded device can have anchoring and/or locking member, and it is suitable to and the heart valve changed A part for film securely locks.In other embodiments, valve bonded device is changed by soft biocompatible material (such as Biocompatibility fabric, silicon, PET etc.) formed, it is assembled to the some parts of external table of support component and/or bridge member Face.In these embodiments, in the inner chamber of valve support during expansion, the soft and compressible feature of biocompatible material permits Permitted its some part and be replaced pole or the extruding of other structural details of valve.Other parts of soft biocompatible material (the replacing valve extruding that it is not expanded) stretches into the inner space between pole and/or other structural details of described valve In.The valve that the protuberance formed by this way engages and grasping is changed, is therefore prevented from it and moves relative to valve support. In other embodiments, changing valve bonded device and include rigidity anchoring piece, what it had is shaped and sized so that they are in institute State and the replacing lobe between its pole and/or other structural details when valve is expanded in the inner space of valve support, can be entered The inner space of film.

Different from the situation of aortic valve, the Bicuspid valve that pathology is relevant is not the most relevant to the calcification increased.This scarce One result of weary calcification is that the valve support that impossible increase the present invention by radially applying the element of stability force fills Put the stability in mitral valve ring.The reason of this point is, the soft tissue of the valve annulus of non-calcification in this case will Simply the radial force applied by expanding in a radially outer direction is made a response, thus tend to reduce support means and Contact between tissue.Thus, in the case of mitral under, extra stabilisation (if necessary) can be only by along vertical The stabilisation element applying power to axis in heart tissue realizes.As such, it is noted that for purposes of the present invention, term " footpath To " refer to the plane dissecting valve when primary lobule closes.Term " longitudinally " refers to become the direction of 90 degree with radial direction, I.e. it is basically parallel to the imaginary line drawn from the apex of the heart to heart root.

Thus, in a preferred embodiment of the invention, the mechanical stability of valve support device is by using stabilisation unit Part (wherein said stabilisation element is suitable to along the longitudinal direction heart tissue be applied stability force) and/or heart tissue Anchoring devices Strengthen.

Thus, in certain embodiments, support component and/or bridge member are equipped with heart tissue Anchoring devices, described Described support component is anchored to heart wall by Anchoring devices securely.The nonrestrictive example of such Anchoring devices includes hook Son or helical structure.

In certain embodiments, heart valve support part farther includes one or more stabilisation element, and its function is Extra axial stability is provided to the described support member in ventricle and/or atrium.Described stabilisation element can be attached to one Individual or two support components.Although in some cases, stabilisation device includes that entity is attached to heart tissue (such as in atrium Or in ventricle wall) one or more elements, but in other embodiments many, described stabilisation device is by heart wall Inner surface on apply pressure and extra mechanical stability be provided, and entity is not connected to internal cardiac tissue.Real at some Executing in example, heart valve support part includes in one or more ventricle stabilisation unit in stabilisation element, one or more atrium Part.In other embodiments, stabilisation element and at least one atrium in heart valve support part is equipped with at least one ventricle Interior stabilisation element.

Above-mentioned stabilisation element can construct in many different ways.Thus, for purposes of the present invention, stabilisation unit Part provides with the form of complete ring structure, part ring, the arm of bending or wing or elongated arm or wing.All this The example of a little various types of stabilisation elements will be described in further detail below.

For being configured to the aforementioned stable element of elongated arm or wing form, described elongated wing can Selection of land cuts out from the same discoid pieces for forming annular brace element itself.By internal ventricle wall is applied pressure, institute State wing for making support means anchoring and stablizing in its operating position.In preferred embodiment as herein described, valve Support means includes only two this anchoring wings.But, some form of device can have the wing of more than two.

Generally, the anchoring wing of this embodiment is interior than other ventricles as above with stabilisation structure in atrium more Long, and will be described in more detail below.In many cases, this increase length of anchoring wing is favourable, because it is permitted Permitted described wing to contact with the larger area on ventricle wall surface, be achieved in the improvement of support means stability.

In some preferred embodiments of this aspect of the present invention, one or two annular brace element comprises only two wings Thing, is separated by 180 degree (+/-several years).Its reason is, wing must be arranged along Bicuspid valve commissure (commissure), To prevent from changing native valve dysfunction during valve is implanted.

But, although it is opposite each other to need wing to be set to, but most of wing is designed as asymmetric, i.e. two Wing is not formed as (separating 180 degree the most definitely) the most opposite each other, in order to avoid in being loaded into deployment catheter Before by the problem in this device curly course.Contrary when discoid pieces is in flat configuration (wing be bent downwardly with Before) they are arranged side by side.

In a preferred embodiment, above-mentioned elongated wing is attached to only one support component, and described support component is In use will become that the support component above in two support components.

In certain embodiments, the first and second support components are suitable at least one position priority bending.

In certain embodiments, the first and second support components each there is the sweep in its deployment configuration, Wherein sweep is suitable to present, in shrinking storing structure, the structure more tightly bent.

In certain embodiments, the first and second bridge members are typically C-shaped under its deployment configuration.

In a highly preferred embodiment, the valve support of the present invention is used for realizing using commercially available aorta Valve changes handicapped mitral valve.(it can be via through stock (trans-femoral) to be currently available that aortic valve Method or transapical approach are implanted) usual balloon expandable material (such as rustless steel-such as Sapien stented valves, by Edwards company manufactures) or self expandable material (such as Nitinol-the most such as CoreValve stented valves, by Medtronic company manufactures) manufacture.

In balloon expandable valve, put and after expansion in its position at valve, the support of valve have rebound existing As.This means just after maximum air bag expansion, when air bag deflation, some that there is support are rebounded, some " close to returning Close ".This phenomenon is the physical-mechanical properties of metal bellows expandable stent.Time in implanted aorta, aorta wall is Elastic, and after it has been expanded, it applies inward force on support, is held in place.But, if this band is propped up Frame valve expands in perfect rigidity pipe/element, and support will have some and rebound the most after the expansion, but rigidity Element will not have any rebounding due to its rigidity, the most always there are some spaces between support and stiffener, and prop up Frame will be held in place by strong power.

Self-expanded stent does not represent phenomenon of rebounding；But, they for be seated in valve support present different Difficulty.Lower, significantly towards outer power towards outer force rate balloon expandable stent applied by Self-expanded stent Difficulty be to ensure that self expandable stented valves launch and be fixed in valve support, and during Cardiac cycle depart from position Put.If valve support has one or more support component (it can apply towards inward radial force), then exist significantly Advantage, valve is attached to the power of valve support and guarantees that valve is without departing from position by its increase.

One or two at least some of tool in some further preferred embodiments of the present invention, in support component Some outer dias are bigger (hereinafter referred to as than the diameter of heart valve annulus (described support component will be implanted in this heart valve annulus) " dilated diameter part " or similar appellation), and the outer dia that other parts of at least one of wherein said ring-type element have Less than the diameter of described valve annulus (hereinafter referred to as " reduction diameter portion " or similar appellation).It will thus be appreciated that described reduction What diameter portion had interrupted the support component of the present invention is otherwise the periphery of annular.

In a preferred embodiment of the invention, one or two support component has two dilated diameter parts and two Individual reduction diameter portion.In another preferred embodiment, support component includes four dilated diameter parts and four reduction diameters Part.

Should be understood that when the valve support of the present invention being implanted in the region of heart valve annulus, each strengthens straight Path portion will form fluid-tight sealing against anatomical annulus tissue.Subtract on the contrary, aperture will be formed in each Between small diameter portion and the neighbouring part of valve annulus, thus allow on the heart side that described support component is implanted at ventricle And between atrium, there is (peri-valvular) blood flowing of limited lobe week.In this way, by the heart of contraction at heart The fluid pressure (and power) that in valve support, (and on the replacing valve in being positioned at described support member) applies will be reduced.Separately Outward, this design reduces room and shrinks the afterload resisted, because it allows controlled limited adverse current, and thus can be to ventricle Function has useful clinical effectiveness, reduces ventricle wall stress and oxygen consumption.

In a preferred embodiment of the valve support device of the present invention, the inside diameter of upper and lower support component Bigger than the height of device (distance between the support component of the most described upper and lower, and be therefore the length of bridge member). This design is needs, in order to allows device can be adapted to for currently available and changes valve through conduit aorta.This valve Example be Sapien Transcatheter Aortic Replacement Valve (your gulf city Edwards of Canada Lifesciences company manufactures).The exemplary expansion diameter of Sapien valve is 26mm, and its a length of 17mm.Therefore fit Valve support for this kind of Sapien valve should have the upper and lower support component inside diameter of about 26mm, and its Length should preferably about 16-17mm (slightly short than valve, do not stretch out from valve and allow stented valves expansion and attached Receive upper and lower ring).

There is above-described length--in the predilation structure of the valve support device of diameter Relationship, bridgeware is each other Away from, i.e. they do not meet at the center of support means, because, as it has been described above, the length of each described bridgeware is than in it Portion's diameter is short.Therefore, in predilation constructs, bridgeware is not provided that any guiding, in order to by valve support relative to leading Silk maintains center.But, this problem can solve by being incorporated to extension or arm, and described extension or arm are attached to Bridge member and/or support component, it allows seal wire centralized positioning during the storing of device, the most even in valve support Be in its contraction, putting can also when (predilation) constructs.Described extension has and is attached to bridge member or support component Lateral edge or end and middle free end or edge, thus the free end of two or more this extension is formed together and draws Guiding element, described induction element can be by the silk centralized positioning at the center through valve support device.These extensions although set up For the most close to each other in the center of support means but still valve bracket can be allowed at the central space of described support means Middle expansion, and the most not inward expansion in valve bracket or outward expansion exceedes the substantial cylindrical of valve support Shape edges.

In a preferred embodiment of the most described valve support device, valve support extension has than existence In valve support (such as upper and lower support component) or change the higher pliability of other elements in valve (i.e. they Rigidity is less).This relatively low rigidity allows stented valves be more easily inserted into above seal wire and enter the lobe of the present invention Membrane support.It is because the diameter of valve is bigger than filament diameter and also bigger than the gap between extension, So the insertion of stented valves makes extension expand, them are allowed to move apart.If therefore bridgeware extension has more The elasticity of high level is then very favorable.

In certain embodiments, the first support component has at least one connection element, and it is suitable to be reversibly coupled to put Place system.At least one connection element can be threaded hole.

In present invention further optimization embodiment, one of first and second annular brace elements or the two be equipped with Biocompatibility at least one wing curtain element textile.Curtain is used as potted component, and it is positioned at support component and two points Between valve annulus, it is therefore prevented from the perivalvular leakage after valve support is implanted in mitral valve ring.

In a preferred embodiment of this aspect of the present invention, single curtain element is attached to the whole periphery of support component. In another preferred embodiment, multiple curtains are attached to support component.In this embodiment, curtain can be located such that at neighbouring curtain Between there is little overlap, be therefore prevented from leakage between which.This curtain seal feature solves the lobe of replacing uniquely The problem of perivalvular leakage after film implantation, because fabric curtain element can be applied by the blood of flowing in response to during ventricular systole Power and move, thus its closeest by its complementary space between support component and two point (or other) valve annuluses Envelope.

In certain embodiments, the second support component under deployment configuration has than the first support unit under deployment configuration The size that the size of part is bigger, as required, one or more retaining elements may or may not be attached and be radially bonded on In heart tissue.

In certain embodiments, the first and second support components are only connected by two bridge members.

Implanting the problem that the device in mitral valve ring would ordinarily be encountered is, is being applied with very by pulsatile heart is dirty Described device deficient in stability in the case of strong power.Many technical characteristics of assembly of the invention are (as previously mentioned and below Describe in detail) purpose be solve this technical problem.These solutions include being incorporated to heart valve support element, such as, have bullet Property deformable inner circumferential, there is in the periphery of support component pressure release cut out region and use slender arm or wing to carry Support component for additional stabilization ability.

On the other hand, the present invention also provides for being applicable to Ink vessel transfusing or putting to change mitral system through the apex of the heart, including: Heart valve support part and the cardiac valve of replacing, described heart valve support part includes that having contraction puts structure and launch structure The first support component made；Have and shrink the second support component putting structure and deployment configuration；At least two bridge member, its Extending to the second support component from the first support component, described bridge member has storing structure and deployment configuration；Wherein first Extend radially inwardly from the first and second support components under deployment configuration with the second bridge member, or longitudinally prolong between which Stretch, and there is no any appreciable radial buckling, as mentioned above；The cardiac valve of described replacing includes expansible anchoring piece and fits In the multiple lobules being fixed to heart valve support part.In order to clearly describe, foregoing relates to including heart valve support The system of part, wherein the two support component is connected by two bridge members.However, it is understood that described system can also be wrapped Include the bridge member of wherein more than two with by two support component interconnective heart valve support parts.And then, the most public The cardiac valve of the system opened can include any technical characteristic described above and described in detail below.

In certain embodiments, bridge member is suitable to be securely engaged the cardiac valve of replacing.Such enforcement In example, bridge member is formed so that it includes a series of folding part or fold (such as z shape fold), its purpose at least partially It is to increase the surface area that can be used for interacting of bridge member with the valve changed.The additional advantage of this embodiment is fold Region additionally aids the transformation between storing (Guan Bi) structure of valve support device and its expansion (opening) structure.Real at other Executing in example, change valve retainer part and include attachment means, such as hook or other mechanic anchors, it connects at one end thereof Receive support component and/or bridge member, and there is the free end for being attached to change valve.

In some embodiments of the invention, system as above farther includes pressure measuring element.These elements May be located at system Anywhere, be included on the surface of valve support device, be attached to the valve changed, and guiding In conduit.In another embodiment, the system of the present invention farther includes to connect terminal, and it allows pacemaker admittance to described system The various parts of system.

Although said system can include the cardiac valve of any suitable replacing, but in particular preferred embodiment, institute Stating valve is artificial aortic valve.The example of suitable prosthetic aortic valve's film includes, but is not limited to following business and can obtain Replacing valve: Sapien Valve (Edwards Lifesciences company of the U.S.), the Lotus Valve (U.S. Boston Scientific company), Core Valve (Medtronic company) and DFM valve (U.S. Direct Row Medical company).

One aspect of the present invention is a kind of to change the mitral method of patient, including step be: by valve support Being placed to the position near main body Bicuspid valve, valve support includes the first support component, the second support component and from the first and At least two bridge member that second support component extends；Allow the first support component to be deployed into from contracted configurations to seat against The deployment configuration of the heart tissue near mitral valve ring or at mitral valve ring；Bridge member is allowed to put structure exhibition from it Reaching deployment configuration, its mode is that they are orientated substantially abutment with primary mitral valve lobule as and are directed at；With permission second Support component is deployed into the region of mitral valve ring, from contracted configurations, the deployment configuration fixed against heart tissue.

In the present case, term " allows " support component or bridge member to launch to typically refer to, wherein said Support element or bridge member are by being encapsulated in deployment catheter the situation keeping being in its compact-folded structure.Subsequently, in institute Stating conduit when recalling, these structures are launched by its shape-memory properties and thus use its deployment configuration.

One key advantage of the described method that cardiac valve is changed is that valve support device can implant dissection valve annulus Region in keep native valve leaflets function simultaneously.

In one embodiment, said method may be used for putting valve support by Ink vessel transfusing (such as through stock) route Part.In another embodiment, method may be used for by putting valve support through apex of the heart route.

In certain embodiments, expand the first support component to include allowing the first support component against heart tissue from expanding ?.

In certain embodiments, method farther includes so that heart attachment means (includes heart anchoring element and stablizes Change element) it is assembled to support component and/or bridge member with the step contacted with heart tissue.In some cases, by inserting Entering and affect the insertion of described attachment means by the controlling silk thread of deployment catheter, described deployment catheter is used for so that valve support Device rotates.In other cases, during valve support device inserts, described attachment means can be covered by sleeve, described Sleeve is removed for allowing described attachment means to insert ventricle wall.In a further embodiment, attachment means it is so structured that The form of anchoring piece, described anchoring piece has the from Kaiyuan City's end arms after two or more sensing, and wherein said distal arm passes through Absorbable suturing part remains closed structure.Subsequently, cycle certain time after described attachment means enters ventricular organization Afterwards (such as between a few hours and several weeks), described suture material dissolves, and thus allows distal arm to use it to open structure.

In other embodiments, said method farther includes so that stablizing in stabilisation element and/or atrium in ventricle Change element and engage internal ventricle wall and/or the step of intrinsic atrial wall respectively.

In certain embodiments, each of expansion bridge member includes allowing bridge member to present deployment configuration, in exhibition Open in structure that they extend radially inwardly from the first and second support components.

In certain embodiments, the second support component expands against left atrial tissue include allowing the second support component certainly Expansion.

In certain embodiments, expand the first support component to include launching the first support component towards substantially a ring-shaped Structure expansion.

In certain embodiments, expand described first support component to include being attached to primary mitral breast by seating against First support component expansion of prominent tendon, and them can not be allowed to carry out with shifting.

In some highly preferred embodiments, after expansion the second support component, primary lobule continues function.

In certain embodiments, expand the first support component to occur before expansion the second support component.At some other In embodiment, the expansion of the second support component is to occur before the expansion of the first support component.

In certain embodiments, expansion bridge member includes allowing bridge member to be extending symmetrically to the from the first support component Two support components.

In certain embodiments, expansion bridge member include allow bridge member from the first and second support components relative to Each other with about 180 degree of extensions.

In certain embodiments, expand the second support component to include allowing the second support component be expanded to deployment configuration, wherein Second support component has the size bigger than the size of the first support component under deployment configuration.Second support component can have There is one or more retaining element being suitable to thrust heart tissue.

In certain embodiments, method farther includes the cardiac valve of replacing is fixed to valve support.To change Valve be fixed to valve support can include by the valve of replacing from shrink put structure be expanded to expanded configuration.Expansion is described The valve changed can include by changing valve described in air bag expansion and/or allowing described replacing valve self expandable.By described more Change valve to be fixed to valve support and can include being radially fixed in valve support described replacing valve.Described in Gu Ding more Change valve can include locking described replacing valve element with valve support element to valve support, so that valve locking will be changed To valve support.Bridge member each can include that bridging locking member and described replacing valve can include multiple locking unit Part, thus lock step includes locking and by multiple locks one in multiple locking members with in bridge joint locking member Determine in element second with another locking in bridge joint locking member.In other embodiments, the valve of replacing is fixed Step to valve support device includes so that valve attachment means is assembled to valve support element and/or bridge member, to connect Close the valve of described replacing.

In a further embodiment, two can individually be put by the said method putting valve support and artificial valve The method of putting combine method be for support means another method for valve.This dominance of strategies It it is the time delay between its storing greatly shortening valve anchoring piece and storing of artificial valve itself.This is critically important , because after valve support is put, the interference with primary mitral valve function can be there is (due to the interference with valve leaflet Cause).One example of this method is to put valve support via Ink vessel transfusing, transseptal route (as herein described) Part, simultaneously in parallel via through the apex of the heart or through stock route storing artificial mitral valves (as known in the art).On the contrary, valve props up Support member by putting through stock or transapical approach, and can change the transseptal storing of valve itself.Thus, method as defined above In one embodiment, change valve and put by the route identical with valve support.In another embodiment of method, change Cardiac valve and valve support put by different routes, the most transseptal and through apex of the heart route.Use these various sides Method is to well known to a person skilled in the art and have been described in several open file to put the valve changed and other devices, Including US 7,753,923 and WO 2008/070797.

In the highly preferred embodiment of the method for the present invention, the cardiac valve of the replacing being fixed to valve support device is Prosthetic aortic valve's film.

Clear in order to describe, the side of heart valve support part it is directed to use with for changing mitral said method of patient Method, in heart valve support part, two support components are connected with each other by two bridge members.However, it is understood that the present invention Endovascular place system may be used for putting the heart of the bridge member including the support component of more than two and more than two Valve support.

List of references

The patent mentioned in this specification is open and patent application is hereby incorporated by reference in its entirety, such as each disclosure or Patent application specifically or is individually described as merging by quoting.

Accompanying drawing explanation

The novel feature of the present invention describes the most in the appended claims.By referring to following illustrative embodiment The features and advantages of the present invention can be best understood from by detailed description:

Figure 1A-1C shows the cardiac valve support structure of the exemplary replacing under expanded configuration.

Fig. 2 A-2C shows the exemplary delivery system of the cardiac valve support structure for putting replacing.

Fig. 3 A-3E shows the illustrative methods of the cardiac valve support structure putting and launching exemplary replacing.

Fig. 4 A-4D shows and puts the cardiac valve changed and be fixed to the example of the Bicuspid valve supporting construction changed Property method.

Fig. 5 A-5D shows the exemplary delivery system for putting heart Bicuspid valve supporting construction.

Fig. 6 shows the sectional view of the Bicuspid valve support member of exemplary replacing.

Fig. 7 shows the valve support of expansion, wherein supported underneath element have than upper support element diameter more Little diameter.

Fig. 8 A and 8B shows the embodiment including sealing member to reduce leakage.

Fig. 9 A and 9B shows the embodiment of the valve support device of the present invention, and wherein bridging element is under its closed structure It is set in the center of described device very close to each other.

Figure 10 shows the exemplary embodiment of valve support, and it is equipped with centralized positioning under expansion (expansion) structure Device.

Figure 11 shows the another exemplary embodiment of valve support, and it is equipped with center under expansion (expansion) structure Positioning devices.

Figure 12 shows another embodiment of the valve support device of the present invention, and it is equipped with the seal wire surrounding extension.

Figure 13 shows the embodiment plane graph of the device shown in Figure 12.

Figure 14 shows the further embodiment of the centralized positioning device of the present invention in the perspective.

Figure 15 shows the embodiment plane graph of the device shown in Figure 14.

Figure 16 shows another embodiment of the centralized positioning device of the present invention, and wherein said device is with funnel shaped element Form provides.

Figure 17 shows the embodiment of centralized positioning device, and it is similar to Figure 16, but funnel element is much bigger.

Figure 18 is the side view that the photo of embodiments of the invention shows, wherein center positioning element divides with bridge member Open.

Figure 19 shows the photo top view of the embodiment shown in Figure 18.

Figure 20 is the side view of further embodiment, and wherein centralized positioning device is only attached to upper support element.

Figure 21 shows the top view of the embodiment of Figure 20.

Figure 22 shows the valve support device with single silk structure.

Figure 23 shows an embodiment of the support component of the present invention with elastically deformable interior periphery.

Figure 24 shows the further embodiment of the support component of the present invention with elastically deformable interior periphery.

Figure 25 shows the another exemplary embodiment of the support component with elastically deformable inner surface.

Figure 26 provides the perspective view of an embodiment of the valve support of the present invention, and it has in its neighboring Four cut out region.

Figure 27 provides the view of the embodiment similar to the embodiment shown in Figure 26, but it only has in its neighboring Two cut out region.

Figure 28 A and 28B each provides side view and the perspective view of valve support, and it is equipped with straight bridge member.

Figure 29 A and 29B show schematically show the embodiment of valve support, and wherein bridge member is equipped with described in permission The mechanism that the height of support member is changed.

Figure 30 shows embodiments of the invention, and wherein lower support element has the external margin being bent upwards.

Figure 31 shows two support components, and but each has identical inner diameter has different outer dia.

Figure 32 shows the embodiment of valve support device of the present invention, and it is equipped with two vertically disposed stabilisation units Part.

Figure 33 A and 33B 10A-10B shows the embodiment of valve support, and each of which has with the formation of shelf-like net Stabilisation element.

Figure 34 shows the embodiment of valve support, and wherein stabilisation element comprises spring-like constriction zone.

Figure 35 shows an embodiment, wherein valve support be equipped with a horizontally stabilizing element and one vertical steady Surely element is changed.

Figure 36 shows the embodiment of valve support, and it has the multiple stabilisation elements being attached to upper support element.

Figure 37 A, 37B and 37C show the embodiment of the valve support of the present invention, and wherein stabilisation element is configured to curved The form cranked arm.

Figure 38 shows the embodiment of valve support, and wherein horizontal annular stabilisation element supports below and above Between element.

Figure 39 A and 39B shows the lobe with a pair elastic lug shape stabilisation element being attached to upper support element Film support means.

Figure 40 shows the support means being equipped with two elongated anchoring wings.

Figure 41 shows the valve support device shown in Figure 40, and this is at it after deployment catheter discharges, and in anchoring Wing has been expanded to it and has opened, after work structuring.

Figure 42 shows the valve support device of Figure 17 and 18, and this is to be implanted to the heart in the region of its heart valve annulus After in dirty.

Figure 43 shows different embodiments of the invention, and wherein anchor arm has the base segments of expansion.

Figure 44 shows the embodiment of the Figure 43 under its expanded configuration.

Figure 45 shows different embodiment, wherein wider than in the embodiment shown before of anchoring wing.

Figure 46 shows have two short wings and the device of two long wings.

Figure 47 shows to be equipped with and opens-the support means (in order to clear, lower support element is not shown) of work structuring.

Figure 48 shows the embodiment opening wing structure with replacement.

Figure 49 shows the valve support containing spiral heart Anchoring devices.

Figure 50 shows valve support, and it includes multiple hook-shaped heart anchoring piece.

Figure 51 A and 51B shows that heart is attached anchoring piece, its have towards after distal arm, described distal arm can be It is maintained at make position by absorbable suture ring during storing.

Figure 52 A with 52B illustrates two different embodiments of cladding element, and cladding element may be used in valve support Heart attachment anchoring piece is hidden during storing.

Figure 53 A and 53B shows use shape memory anchoring piece, and it is maintained at straight configuration by trocar sheath during putting Under.

Figure 54 shows clip like heart tissue anchoring piece, and it is particularly suited for support component is attached to valve annulus.

Figure 55 shows the valve support device of the present invention, and it is equipped with two different types of valve bonded device.

Figure 56 A and 56B shows that support component, described support component are equipped with the lobe of soft biocompatible material structure Film bonded device.

Figure 57 provides the schematic side elevation of the Example support part of the present invention, show and is on mitral valve ring Position, and show the fabric curtain of the interior section being attached to ring.

Figure 58 shows the side view of the another exemplary top loop (upper support element) of valve support of the present invention, aobvious It is shown in the position on mitral valve ring, and shows the fabric curtain of outside (far-end) part being attached to ring.

Figure 59 provides the perspective view of the Exemplary upper support component of the valve support of the present invention, and it is equipped with multiple Fabric curtain.

Figure 60 shows the exemplary design of the fabric curtain of the present invention.

Detailed description of the invention

The present invention is the most relevant with cardiac valve support structure, and it is suitable for implantation at primary cardiac valve or native valve ring In or near, and be suitable for replacing cardiac valve provide support.Supporting construction is suitable to interact with the cardiac valve changed, To be fixed in native valve or native valve ring or neighbouring implantation position.In certain embodiments, supporting construction is fitted In be positioned in mitral valve ring or near, and be suitable to the cardiac valve with the replacing put later and interact, changing Valve is in position, to replace primary mitral function.In a particular preferred embodiment, the cardiac valve of replacing is behaved Make aortic valve.

The present invention also provides for the Ink vessel transfusing implantation process of two steps, for the primary Bicuspid valve changing patient.Generally, First supporting construction is positioned in mitral valve ring or neighbouring and be secured in place.The cardiac valve changed is subsequently fixed to support Structure, will change valve in valve annulus or near in position.By implanting supporting construction with two steps and changing valve, Described replacing valve can have less storing profile, because due to the existence of supporting construction, it need not be expanded too much with contact Primary structure.This eliminates has the big needs changing valve putting profile, and this big replacing lobe putting profile Film may require that when attempting and single-piece mitral valve implant being positioned in primary Bicuspid valve (implant assembled the most in vivo).

Figure 1A-1C shows the exemplary embodiment of valve support under expanded configuration.Valve support 10 includes first Support component the 12, second support component 14 and support 12 the first and second bridge members extending to the second support 14 from first 16.Figure 1A shows the perspective view of valve support 10, and Figure 1B and 1C respectively illustrate valve support 10 side view and Top view.As shown in Figure 1B, each bridge member 16 includes valve bonding part 18.

In certain embodiments, support component is general toroidal (such as seeing Fig. 1) under its expanded configuration.But, at the heart Dirty anatomical structure aspect, with the difference of patient, patient may require that support component is of different sizes and constructs.Support component Can have any structure the most as required to be fixed to any organizational structure.Such as, support component can have generally oblong Structure.It addition, support component need not have identical rough structure.Such as, upper support element can have general toroidal Shape and supported underneath element can have generally elliptical shape.Bridge member is operatively connected the first and second support units Part, and the most inwardly and axially away from the first support component before extending radially outward towards the second support component Extend.Such as, in the embodiment of Figure 1A-1C, before extending radially outward towards support member 14, bridge member 16 is from propping up Support member 12 direction radially inward extends and extends axially away from support component 12 and towards support component 14.Bridge member Valve bonding part be disposed radially inwardly relative to support component.Bridge member is biased into figure by valve bonding part Structure shown in 1A-1C, described valve bonding part is disposed radially inwardly relative to support component.Because they are by towards this structure Make bias, so they are suitable to apply radially inner power, to be determined by the cardiac valve being expanded to the replacing of expanded configuration subsequently Position is in bridge member (as described below).Bridge member is consequently adapted to engage the cardiac valve changed, with the heart valve that will change Film is fixed to valve support.

In the embodiment shown in Figure 1A-1C, the bridge member discontinuous position around support component is from support Element extends.The most in this embodiment, bridge member extends around support component from support component the most always.If they are these Sample, then valve support will have the shape of substantially water leakage.Therefore, bridge member is not the fully extended portion of support component. Although the embodiment in Figure 1A-1C shows two bridge members extended in discontinuous position from support component, but lobe Membrane support can include the bridge member of the more than two extended from support component along support component in discontinuous position.

In the embodiment of Figure 1A-1C, bridge member is also symmetrically extended from the first and second support components.That is, at valve In at least one view of support member, there is at least one line or the plane extending through valve, form symmetrical valve support The part of part.Such as, with reference to Fig. 1 C, extend through bridge member and connect the line of this bridge member and form the right of valve support Claim part.Or, such as with reference to Figure 1B, the vertical line extending through valve support center forms the antimere of valve support Point.

In certain embodiments, the resilient material manufacture of the first and second support components and bridge member, resilience material Material can be deformed into storing structure and is still suitable to self expandable to expanded configuration, has the one or more portions by airbag inflation simultaneously The optional extra expansion of part.Such as, support member can use Nitinol manufacture, depends on its superplastic character.In some embodiments Middle valve support apparatus has the material manufacture of shape-memory properties, such as Nitinol, and is suitable to be heated to its transformation temperature Its expansion remembered configuration is returned to after degree.Some realities that the valve support use such material of such as Nitinol manufactures wherein Executing in example, utilization is shape-memory properties and superplasticity property.In the embodiment of Figure 1A-1C, valve support 10 is suitable to Return to shown expanded configuration, or by self expandable (depending on the superplasticity of material), or by being heated to its transition temperature Above (such as by exposing to body temp).

Once supporting construction is expanded and in position in primary Bicuspid valve, then shrink the heart valve of the replacing putting structure Film advances through the first supporting construction and is positioned in bridge member.Change valvular expansion (such as air bag expansion, from Expansion etc.) not only allow the cardiac valve changed expand, and on bridge member, also apply expansionary force, make them radially further It is outwardly directed to native valve ring extension.The valvular expansion changed makes to change valve and engages bridge member and by replacing Cardiac valve is fixed to valve support.Because bridge member is biased towards they approximately radial structures extended internally, institute On the cardiac valve changed, apply radially inner power with bridge member, help will to change valve in position.

Generally, before artificial (prosthetic) valve is expanded in support means, described device has " closed " structure Making, bridge member is juxtaposed with one another, has minimum range (distance of the most about 1-2mm) the most between which.In this Guan Bi Under structure, be used for putting the seal wire of valve support (with being used subsequently to put change valve) two relative bridge members it Between be extruded.So that bridge member extruding or the ability optimization of grasping seal wire, the surface of bridgeware can be non-flat forms, Such as from the side time, they can have corrugated or serrate profile.In an especially preferred design, wave Or sawtooth form will include three ripples or three teeth.But, in many cases, bridge member can include less or more This ripple or tooth.Preferably, in this embodiment, the design of bridge member makes, and is changing valve by axially at described bridge Between connection member towards desired locations guide time, bridge member be change valve by providing minimum frictional resistance.With this Mode, be inserted from above into changing valve will result in the lateral displacement of bridge member rather than valve support device to bottom Move.In order to realize this effect, the bridge member of valve support with suitable material construct, such as Nitinol, cobalt-base alloys or Rustless steel, and it is designed to suitable shape, to allow to be converted into the radial dilatation of bridgeware from the power of motion in downward direction. Show at Fig. 9 A and 9B and be inserted in changing valve above the silk in the valve support inner space of the present invention.Thus, will After this kind of valve support 330 is seated in the region of mitral valve ring, bridge member 332c is closely positioned together, Thus swallow up seal wire 334, as shown in Figure 9 A.Subsequently, valve 336 is changed inserted above at silk, preferably via transseptal route (trans-septal) insert, thus valve reaches mitral valve ring (valve support position valve annulus from left atrium Top).When allowing valve advance down at silk, it contacts with juxtaposed bridge member.The design of these components makes, When valve is pushed away further downward, the downward force vector deflection radial direction applied on bridgeware by valve, with this side Formula, bridgeware 332o moves apart, and " opening " and thus permission valve insert (as shown in Figure 9 B) by them, directly above silk Arriving desired location to valve, this position is preferably at the level of valve annulus, in support means and be arranged so that it is long Axis is parallel to the long axis of described support means.The advantage of this embodiment is, after changing valve and implanting, it is ensured that bridge joint structure Part keeps and changes valve contact, and does not disturb the ability of its function, is therefore prevented from that such as adverse current is such functional asks Topic.

The further detail below of exemplary expansion process describes later.

As it has been described above, in some currently preferred embodiments of the present invention, valve support device is equipped with in storing process The middle device that seal wire is maintained at described device center.The details of some preferred embodiments of these centralized positioning devices will under Literary composition describes.Thus, Figure 10 and 11 shows the exemplary embodiment of valve support under expanded configuration.Valve support 400 is wrapped Include the first support component (top loop) the 401, second support component (lower loop) 402 and extend to second from the first support member 401 First and second inflexion bridge members 403 of support member 402.

In the accompanying drawings, bridgeware is shown as the direction with inflexion.But, present invention additionally comprises have minimum to Interior bending (such as: along the interior 0.1mm-2mm that bends to direction) or does not has aduncate bridgeware.

Figure 10 provides the perspective view of valve support 400, and Figure 11 shows the top view of same device.Such as Figure 10 institute Showing, each bridge member 403 includes towards inwardly directed extension 404, and it is constructed in a manner such that every a pair extension is formed Guided rings, described guided rings can be around the seal wire being placed centrally.However the guided rings formed is incomplete ring, each There is small-gap suture between bridgeware extension on side, but these small-gap suture are less than the diameter of seal wire, be therefore prevented from it from guiding " run away " in the range of the restriction of ring.In other preferred embodiments (accompanying drawing is not shown) of this device, bridgeware extension is overlapping (thus one is bigger than another, has somewhat larger diameter), thus between which entirely without gap.This design Advantage be that it reduces the chance " run away " in the range of the restriction of ring of seal wire.

Extension 404 is constructed so that, when belt supporting frame replacing valve is expanded in valve support, extension is by expanding Open the motion of valve and expand, and at the end of described expansion, each extension is properly seated in the imagination of valve support At cylindrical edge, and it does not expand in stented valves or expand into beyond the cylindrical edge of valve support.Diagram bag Including four extensions 404, each bridgeware has two.But, the scope of the present invention is not limited to this quantity, and includes having Realize the support means of any quantity extension necessary to expectation target (will device around seal wire centralized positioning), and from bridge joint The either direction of part extends.Each bridge has the advantage of more than one extension, and it improves and leads in gap between extension The stability of silk, as shown in the top view of Figure 11.

In the preferred embodiment of device, extension 404 (also referred to as " centralized positioning " element) has and support component The elasticity (different hardness) that (ring) 401 and 402 is different, and can also have the elasticity/hardness different from bridging element 403.Excellent Selection of land, compared with other device elements, extension 404 has higher pliability (i.e. they have less rigidity).This relatively Low rigidity allows stented valves to be more easily inserted into above seal wire and enter in the valve support of the present invention.Because lobe The diameter of film than filament diameter is bigger, and also bigger than the gap between extension, so belt supporting frame lobe The insertion of film makes extension expand, and allows them move apart, and thus, allows them have ratio and can construct device as previously mentioned The higher elasticity of other elements be favourable.

Figure 12 shows another embodiment of the valve support device of the present invention, 400, wherein surround leading of extension 411 Silk band is formed, and described band has not exclusively cut out from bridgeware and with backward bent intermediate, as shown in the figure.With this side Formula, " window " 410 (corresponding to bent intermediate to form the material of extension 411) is formed in bridgeware.Such as can lead to Cross cut and manufacture this embodiment.Device cuts out an advantage of design, it is allowed to simple and cost-effective manufacture process. Further advantage is that, in valve support between valve expansionary phase, extension by sideways against, i.e. to return be expanded to its Home position in bridgeware, therefore ensures that extension is located exactly at the cylindrical limit of valve support after valve is expanded Edge does not expand in valve or expand into beyond the edge of support member.The complementary sized of extension 411 and window 410 and Shape is clearly shown that in the top view of this embodiment shown in Figure 13.

Figure 14 and 15 gives another embodiment of the present invention, wherein surrounds the seal wire of extension 415 by bridgeware Cut out and manufacture and design.Free lateral edge (it becomes the middle edge of the extension 415) quilt of the bridgeware being partly cut out Cutting further, thus it is arch or semi-cylindrical.In this way, the arch of every a pair bridgeware extension 415 is freely Edge is in the incomplete guided rings that is centrally formed of expansion support means, as shown in FIG. 14 and 15.Reality as shown in Figures 12 and 13 Execute in example, cut out bridgeware extension in bridgeware, leave " window " 416.The advantage of this design is extension and " window " Between relative direction.Thus, during the replacing valve of belt supporting frame inserts in the central space of support means, bridgeware Extension 415 can bend (power applied in response to the stented valves by being inserted into) along required direction, and this depends on valve Be from upper (base portion) side of valve annulus insert or from (top) side insertion.Such as, for the support means shown in Figure 14, as The most described device launches in mitral valve ring, then change valve and put via transseptal method, and the valve of valve insertion subsequently props up The direction of support member is from top, as shown in the arrow of Figure 14.When valve inserts in the direction, it makes to cut out extension 415 Downwardly " window " motion, and when valve is expanded, this motion continues, until cut-out portion correctly returns to it in bridgeware Home position, and thus after putting, extension do not expand into valve bracket or expand into the framework of valve support with Outward.The direction is only exemplary, and the identical concept may be used for transapical approach, wherein the direction by contrast (valve to In upper insertion valve support), and cut-out portion and " window " be designed to be in opposite direction along with shown in Figure 14 just Direction.The top view of this embodiment shows in fig .15.

Figure 16 shows another embodiment of the present invention, and the seal wire wherein surrounding extension 420 is formed in support means Intracardiac substantially funnel-shaped guiding element.Funnel shaped advantage be it around and surround the relatively long part and thus of seal wire Guarantee that it is placed in the middle, thus reduce silk and slide into the chance beyond middle section.Funnel shaped 421 ratio shown in Figure 17 is shown in Figure 16 Bigger shown in embodiment, so that stented valves more easily introduces middle section (i.e. entering funnel), because institute The diameter stating replacing valve is bigger than the diameter of silk.

In Figure 16 and 17, infundibulate extension is close to each other, there is gap between them, and this gap should be more straight than seal wire Footpath is less, to prevent it from departing from from funnel.As it was previously stated, in a preferred embodiment, infundibulate extension is designed so that one Individual extension overlapping with another (because it is slightly longer, have slightly larger diameter), the most very close to each other, thus make Obtain the chance minimum that seal wire departs from from funnel.

Figure 18 (side view) and Figure 19 (top view) is the photo of apparatus of the present invention, wherein centralized positioning extension and bridge joint Component is separately.Top loop is shown as 430.Right bridge member is shown as 431.Centralized positioning device extension 432 is not from bridgeware Extend, but the portion that will extend over separates with top loop.Centralized positioning extension can only extend from top or lower loop, or from top Extend with lower loop, as shown in this situation.In the medial side of centralized positioning extension, there is semi-cylindrical extension 433, it makes seal wire centralized positioning and prevents it from " running away ".Additionally photo shows stabilisation/Anchoring devices 434.

Figure 20 (side view) and Figure 21 (top view) is the photo of another embodiment of the present invention, and wherein centralized positioning extends Bridge member is separated by portion, and wherein infundibulate centralized positioning device from two separate arm extensions, (it is stretched from top loop Go out) extend.Top loop is shown as 440.Right bridge member is shown as 441.In the preferred embodiment, centralized positioning device extends Portion 442 does not extends from bridgeware, but the portion that will extend over separates with top loop.Other designs in being included in the scope of the invention In, centralized positioning extension can only extend from lower loop, or extends from both upper and lower rings.At centralized positioning extension Medial side, there is semi-cylindrical extension 443, it forms funnel shaped and makes seal wire centralized positioning and prevent it " de- Escape ".Additionally photo shows stabilisation/Anchoring devices 444.

In the embodiment shown in Figure 1A-1C, bridge member and support component are separately and by any suitable technology (such as soldering) and be fixed to individual component each other.In some embodiments replaced, support component and bridge member are made Make as being individual unit, it is not necessary to the parts (in the exemplary embodiment of Fig. 3 A-7 the most hereafter) that will be fixed to one another.Example As, in certain embodiments, the manufacture of valve support is simplified, because it is with single tubular form memory material (such as nickel Titanium promise) manufacture, it is pre-formed as has predetermined expansion ratio and the cardiac valve of replacing is held in place required power.At this In some this kind of preferred embodiments, valve support device constructs with single silk, and described single silk is the most by this way Shaping, it constructs upper support element, lower support element and two or more bridging elements between which.This kind of reality The example executing example shows in fig. 22.The suitable wire material that may be used for manufacturing this kind of valve support includes, but is not limited to Biocompatibility metal and metal alloy, Nitinol, cobalt and rustless steel.One advantage of this design is that the simplicity of its structure makes Obtain manufacturing cost to reduce.The further significant advantage using single silk (rather than the wider lane described in Figure 1A) is that it is permissible It is retracted to the least size, thus it may be inserted into minor diameter deployment catheter, thus provides the cross section profile of reduction.

As it has been described above, in some preferred embodiments of the valve support device of the present invention, one of support component or two Person can construct so that its inner surface or direction elastically deformable radially in the periphery.The support component constructed by this way is thus Can change, in the central space being inserted into valve support device, the power applying to be radially orientated on valve.Thus, Figure 23 illustrates The exemplary embodiment of the support component of the valve support of the present invention.Support component 510 is annular, and can represent Ben Fa The lower loop of bright dicyclo valve support or top loop or two rings.Ring shown in Figure 23 generally circular in shape；But be suitable to Implant any shape in the valve annulus of heart (such as oval or rectangle) to be included within the scope of this invention.In Figure 23 institute In the preferred embodiment shown, support component 510 includes cutting out region 512 and cuts out region 513, described in cut out region 512 from unit The middle section (from " body " of ring) of part cuts out, described in cut out region 513 from the interior section of element (from the interior periphery of ring Cut out).In this example embodiment, exist four such cut out region 512 and 4 such cut out region 513.These cut out region Quantity and shape be only exemplary, and any quantity and shape can be used.For manufacturing the exemplary material of support component Material is biocompatibility metal or alloy (such as Nitinol or rustless steel).The purpose cutting out both regions 512 and 513 is to manufacture The support component of elastically deformable at the interior periphery of ring, applies footpath with the valve at belt supporting frame when expanding in support component To inward force.

Exemplary dimensions for apparatus of the present invention: such as, (the support of grown form under " shelving " state (baseline stent), after ring launches in mitral valve ring, but launches in ring at the valve of belt supporting frame and expands Zhang Yiqian) inside diameter of support component 510 can be 25mm.Exemplary valve is expanded in support component, and Sapien is 26mm, it is expansible air bag, and airbag inflation is to 27mm, and it occurs some resiliences immediately after the expansion, reaches 26mm straight Footpath.Because valve is expanded in support component, so inner loop diameter (after expansion) now is directly similar to valve, thus prop up The inside diameter of support element ring is 26mm now.Because, as described in example, a diameter of under the state of shelving of support component 25mm, with compared with the elasticity capacity of support component in the design of the present invention, support component applies radially now on valve Internal force, and be thus fixedly attached to valve and prevent valve disengaging configuration.Certainly, size setting can be according to desired valve And change, and this is only exemplary.

Figure 24 shows the exemplary embodiment of the support component of the valve support of the present invention.Support component 520 is ring Shape, and the lower loop of the valve support of the present invention or top or this two rings can be represented.In the preferred reality shown in Figure 24 Execute in example, support component 520 include three cut out region 522 and three cut out region 523, described in cut out region 522 from element Middle section (from " body " of ring) cut out, described in cut out region 523 and (cut from the interior periphery of ring from the interior section of element Go out).These quantity cutting out region and shape are only exemplary, and can use any quantity and shape.

Figure 25 shows the exemplary embodiment of the support component of the valve support of the present invention.Support component 530 is ring Shape, and the lower loop of the valve support of the present invention or top or this two rings can be represented.In the preferred reality shown in Figure 25 Execute in example, support component 530 include three cut out region 532 and three cut out region 533, described in cut out region 532 from element Middle section (from " body " of ring) cut out, described in cut out region 533 and (cut from the interior periphery of ring from the interior section of element Go out).These quantity cutting out region and shape are only exemplary, and can use any quantity and shape.In this embodiment In, each cuts out region 532 and includes extra cutting out region 534, and it changes and increases the elasticity of support component.This additionally Any quantity cutting out region or shape within the scope of this invention.

In some currently preferred embodiments of the present invention, one of support component or both be included in " cutting in its neighboring Go out " region, thus allow limited heart valve week blood flowing (i.e. between ventricle and atrium), as reducing the heart shunk The power applied in support means and the means additionally reducing the afterload that ventricular systole is resisted.In these embodiments, on The shape of portion's support component (top loop) not exclusively covers the edge of valve annulus and does not have smooth-shaped, but has permission two The contour shape that individual ring is parallel:

A part for 1-support component has the diameter (i.e. expansion diameter part) bigger than valve annulus diameter, is thus propping up When support structure is expanded above valve annulus, the larger diameter of this shape prevents it from " falling " to the left heart from atrium through valve annulus Room, and thereby assist in valve support is maintained at the destination locations in mitral valve ring.

One or more parts of 2-support component have diameter (the diameter portion that i.e. reduce less than valve annulus diameter Point), thus when support component is expanded above valve annulus, between atrium and ventricle, there is be held " open " or many Individual hole.This actually causes leakage, or the most controlled " MR " (two point adverse currents), and its size is pre-by size and the quantity in hole Fixed.

Clinical rationale illustrates:

In this it is to be understood that " the controlled MR " that deliberately make changes for being subjected to valve to correct it First there is clinical rational for the patient of already present MR.Thus, the patient of the valve replacing for MR is experienced by 3 grades Or 4 grades of MR, this forms obvious clinical symptoms, it is thus necessary to carry out clinical intervention.Most preferably, target is to change valve and arrival Zero MR (does not reveal).But, the most acceptable it is a process thus patient keeps little remaining MR (1 grade), Because this is by more much better than the stage 4 before this procedure, and because assembly of the invention allow transcatheter implantation rather than For valve change surgical operation, in result " cost (cost) " be stage 1MR (there is minimum invasion procedure) rather than Zero MR (use surgical method), this is useful to some patients clinically, especially those is had the highest operation For the patient of the concurrent pathological changes of risk.

This embodiment (wherein neighbouring part of valve annulus and reduce diameter portion hole between each and allow ventricle and the heart Limited between room lobe week (para-valvular) blood flowing) additional advantage be, after valve support is implanted, Keep " controlled " or " limited " reflux flow (stream during by lobe week hole blood from ventricular systolic to atrium Dynamic).It reduce ventricular afterload (power that left ventricle (LV) is resisted when shrinking), and in the situation of Assessment of Left Ventricular Systolic Function difference Under be favourable.This can be the most useful in the minimizing of afterload for improving left ventricular function, decreases LV wall Stress and oxygen consumption.

Exemplary mitral ring diameter for 35mm.The inside diameter of upper support element (top loop) is suitable to band The expansion diameter of valve changed by frame, and described belt supporting frame is changed valve and should be expanded in valve support.For exemplary Sapien 26mm valve, the inside diameter of upper support element is of about 26mm.The outer dia of support component should than valve annulus diameter more Greatly, in order to anti-locking apparatus " drops " in ventricle, and contribute to prevent perivalvular leakage.Therefore, for this example, outside selected 37mm Portion's diameter.But, the diameter having at least partially of upper support element is less than 35mm (such as by one of the neighboring of ring Cut-out portion is manufactured so that it is there is the diameter of only 33mm in point)-thus shape between mitral valve ring and the external margin of top loop Become aperture.During the ventricular systole of cardiac systolic stage, one or more holes are used as pressure release mechanism, and they discharge applying Some pressure (upward force) on valve support-valve device, and thus reduce the risk of equipment disengaging configuration.

With reference now to accompanying drawing, it illustrates the distinguishing feature of current described embodiment.

Thus, the perspective view of the exemplary embodiment of the valve support of the present invention under Figure 26 provides expanded configuration.Lobe Membrane support 600 includes the first support component (top loop) the 601, second support component (lower loop) 602 and from the first support member 601 the first and second bridge members 603 extending to the second support member 602.In which it can be seen that top loop 601 has Four regions of small diameter (from ring neighboring cut out region), it is labeled as 604.The number in this small diameter region 604 Amount is only given by example, and the shape and size in each such region 604 are the most only exemplary.The present invention includes appointing What shape and size, it is considered clinically relevant.

Figure 27 shows the perspective view of another example of the present invention, wherein the most aobvious in the top loop 601 of valve support device Show that two reduce diameter region 604.

In some embodiments of the valve support device of the present invention, bridging element (can be two or more) can be The most straight (rather than towards device the most aduncate).This embodiment shows in 28A-28B, it illustrates The exemplary embodiment of valve support, it is equipped with the straight bridge member under expanded configuration.Valve support 610 includes One support component the 612, second support component 614 and support 612 the first and second bridges extending to the second support 614 from first Connection member 616.Figure 28 A shows the side view of valve support 10, and Figure 28 B shows the perspective view of valve support 610. In the figure it can be seen that a pair supports extension 618, it medially extends from upper and lower support component, in support means Intermediate formation seal wire centralized positioning device (as in above-detailed) of inner space.

In certain embodiments, the height of valve support (measures the second support member from the base portion of the first support member Top) it is that 1cm arrives about 50cm, to adapt to the valvular height changed, the such as cardiac valve of belt supporting frame.At some In embodiment, height is more than 5cm.In certain embodiments, the height of valve support is of about 1cm to about 2.5cm.Example As, in expanded configuration, the cardiac valve of belt supporting frame has the height of about 17.5mm.As above-described, each supports unit The outer dia of part is substantially in the scope of 30-50mm, and the scope of its inside diameter substantially 23-29mm.Valve support Thickness is substantially in the scope of 0.25-0.6mm, more preferably 0.4mm.It should be noted that certainly, these labellings are only exemplary and not It is restricted by any way.

In one embodiment, as shown in figure 29, the bridge member 638 of valve support device is equipped with mechanism 640, described Mechanism allows the height (i.e. distance between the support component of upper and lower) of device to change: or lengthen, or (such as Figure 29 institute Show) shorten.In Figure 29 A, valve support is shown in its elemental height, and Figure 29 B shows and highly reducing it After same support member.Suitably mechanism includes rotatable screwing element, and its length can be by being rotatably coupled to described element The control silk of one end and change (shorten or lengthen).In the embodiment replaced, pulling mechanism (is such as equipped with internal wire drawing Hypotube (hypotube)) be arranged so that when operator pulls described silk, the only distal portions of bridge member is pulled, So that bridge member shortens, thus reduce the whole height of valve support device.

In certain embodiments, the valvular height that the aspect ratio of valve support is changed is little.These numbers are only Exemplary rather than restrictive.It addition, two annular brace elements can have different size.Such as, two support components are such as Fruit general toroidal then can have different-diameter.First support member element has than the second support member unit in certain embodiments The diameter that part is bigger, because its anatomical position being placed in is bigger than the anatomical position that the second support member element is placed in.At figure In embodiment shown in 1A-1C, owing to expanding in bigger left atrium compared with less left ventricle, mastoid process tendon in left ventricle With the existence of muscle He other supporting constructions, support component 12 can have the diameter bigger than support component 14.Above and below The possible difference of support component size is described in detail below.

In other embodiments, presently disclosed lower support element has bending or flexing edge.The example of this embodiment In fig. 30, wherein the outward flange 658 of lower support element 660 is bent upwards in son display.Anatomical structure and chi in left ventricle Very little make heart contraction during valve support device may with from described ventricle by the normal blood of aortic valve conveying phase During interference, this kind of embodiment is very useful, such as by making a part for blood away from aortic valve.

In most of embodiment of valve support disclosed herein, the size of circumferential support element can be such as Figure 31 Shown by two different sizes restriction outer dia 644e and inside diameter 644i.Can be seen that shown in this Fig Two support components 642 have identical inner diameter, and its outer dia is different.Should be understood that inside diameter limits for changing lobe Film implants the free space in valve support device, and outer dia need identical with the space in primary mitral valve ring (with Just the stable implantation of valve support is allowed).Because the different valvular expansion diameter of commercially available replacing is (such as Prosthetic aortic valve) and mitral valve ring diameter difference (between patient) of dissection, so the scope of valve support device Needs have been fabricated to certain usable range, thus clinician may select valve support, and it has and is applicable to allow replacing valve The inside diameter implanted, and have and the outer dia of the space same size in mitral valve ring.

Support component does not have cladding element in the embodiments described herein.But, in certain embodiments, one or Multiple support components can have cladding element, such as, seal skirt part, to improve in the cardiac valve changed and supporting construction week Enclose the sealing flowed with blood therein.Cladding element can be any kind of material, and it is around support component and offer The sealing function (such as it can prevent the fluid between valve support and heart wall from leaking) strengthened.In some embodiments In, cladding element can be attached (such as by using biocompatibility bonding agent) outer surface to support component.Implement at other In example, cladding element could attach to the inner surface of support component.

In certain embodiments, one or more supporting constructions are coated over the material of such as polyester textile (such as terylene) In.Alternatively or in addition, one or more bridge members can be coated in the polyester textile of such as terylene.

In some embodiments, valve support device may further include and is attached to upper support element, lower support unit Part or one or more stabilisation elements of two support components.The purpose of stabilisation element is by extra unbroken loop structure The stabilisation unit of (being similar to the upper and lower support component of itself in some cases), part ring or bend arm form Part, the stability increasing the multiple directions implanting valve support device (and the most also improves to implant and changes the stablizing of valve Property), the most described structure is provided so that surface and/or the intrinsic atrial of at least some of and internal ventricle wall of its length Surface next-door neighbour's juxtaposition (in the case of stabilisation element is attached to upper support element) of wall.Because atrium and the inside of ventricle The curvature of wall can be relative to two orthogonal axis (level and vertical) restriction, so stabilisation element can be with water Level land arranges (being i.e. basically parallel to the horizontal axis of valve support device) or is vertically arranged and (is i.e. basically parallel to valve support The vertical axis of device).It addition, in certain embodiments, stabilisation element is arranged to them and is not parallel to level Axis is also not parallel to vertical axis, and is arranged to acutangulate with in these axis.

In some cases, stabilisation element (it can be formed with elastic or plastic material, and this will be described below) quilt It is fabricated to the integral part of valve support device.In other cases, described stabilisation element (is passed through this area by separately fabricated Known casting, grinding, cut or any other suitable technology), and stabilisation element is by soldering or laser welding It is connected to one or two support component.

Figure 32 shows the valve support device 1300 of the present invention being equipped with vertically disposed annular stabilisation element.As Shown in the drawings, the apical ring 1310 of upper top is attached to upper support element 1320 at lower portion, and its upper part It is arranged in atrium 1330, is in close contact with intrinsic atrial wall.On the contrary, bottom ventricle ring 1340 is held thereon is attached to bottom Support component 1350, and lower portion is arranged in ventricle 1360, is in close contact with internal ventricle wall.

In the case of the stabilisation element of level, element itself can (as above) be unbroken loop, part ring or Curved elongated arm.Although in the embodiment of some unbroken loop (shown in Figure 32), the stabilisation element silk or solid of single ring Body band constructs, but in other embodiments, it is it is so structured that the form of shelf-like net.Figure 33 A shows the one of the type Individual embodiment, the most netted stabilisation element 1390 is directly attached to the upper support element 1380 of valve support device 1370. Alternatively, as shown in Figure 33 B, netted stabilisation element 1390 can be connected to upper support by extra bridge member 1400 Element 1380, described extra bridge member is used as spacerarm, increases stent mesh stabilizing member 1390 and described support component Separating distance between 1380.

Although stabilisation element is generally configured so that its contour shape is smooth surface, but at a preferred embodiment In, as shown in figure 34, this smooth surface is separated by one or more constriction zones 1410, and wherein said region is used as spring-like Element, increases described stabilisation element 1420 and can be applied to internal ventricle or the power of atrial walls, and thus strengthen described stable Change element makes the ability that valve support device 1370 is stable.Device shown in Figure 34 comprises two vertical stabilisation units Part is attached to the stabilisation element of the ventricle of lower support element and is attached to the stabilisation in atrium of upper support element Element.In other forms of this embodiment, valve support device can be equipped with a vertical stabilisation element and (be attached to one Individual support component) and a horizontally stabilizing element (being attached to another support component).In some other embodiments, valve props up Support arrangement contains only one this stabilisation element (level, vertical or angularly).In a further embodiment, single Valve support device can comprise a stabilisation element, and described stabilisation element contains one or more constriction zone 1410, As shown in figure 34, and one or more stabilisation elements of any other type described and disclosed herein.

The further example of the valve support device being equipped with the combination of different stabilisation element shows in Figure 35.By This, the lower support element 1480 of valve support device 1430 is equipped with vertically aligned ring-type ventricle stabilisation element 1460, And the atrium stabilisation element 1470 of horizontal aligument is connected to upper support element 1440 via extra bridging element 1450.To the greatest extent Pipe only show two extra bridging elements 1450 in the figure, but if necessary, multiple such elements can be incorporated to In device.Certainly, in other forms, the structure of the stabilisation element shown in Figure 35 can overturn, thus valve support dress Put the lower stabilizer element comprising level and vertical upper stabilizer element.As it has been described above, can use in the case of Shi Dang The all possible combination of all kinds stabilisation element disclosed herein.It shall yet further be noted that more than one stabilisation element can To be attached to one or two support component.Figure 36 shows an embodiment of the type, wherein valve support device 1500 Upper support element 151 be equipped with several (being three in this case) non-level angled atrium stabilisation element 1520。

As above, stabilisation element need not provide with the form of unbroken loop, it is possible to have part ring or bending are thin Long-armed form.The various examples of the type of a rear stabilisation element show in 37A, B and C.(in order to clear, at these figures In only show the upper support element of valve support device.It should be noted, however, that in all cases, these valve support fill Put the first upper support element all including being implanted in above anatomy valve annulus and second time that is implanted in that this valve annulus is contrary Portion's support component).Thus, Figure 37 A shows the upper support element 1540 of the valve support device of the present invention, wherein said lobe Film support means is connected to two curved elongated arms 1560 and by its stabilisation, and described curved elongated arm is along internal ventricle wall 1580 Arrange vertically downward.In this example shown in the drawings, stabilisation element 1560 elastomeric material (such as based on cobalt conjunction Gold, Nitinol, rustless steel and other biological adaptability metal and metal alloy).Bend arm is generally of the length of 1mm to 50mm Degree, preferably about 20mm.As shown in drawings, the upper part of each stabilisation element 1560 is angled, it is thus possible to Through heart valve annulus 1600 around.In certain embodiments, elongate curved elastic arm could be configured such that at them In preload condition.The elastic performance of stabilisation element will make, and described element is prone to grasp valve annulus and inferior to valve annulus Ventricle wall on apply outward force.In the alternative embodiment of this aspect of the invention, the elongate stabilization element of bending is permissible Construct with plasticity deformable material, such as rustless steel, alloy based on cobalt and Nitinol.In this case, use is vised Or slender arm is molded in around valve annulus by compaction tool.By this way, the upper part of slender arm will firmly grasp valve Ring, and low portion outwardly and downwardly biases along ventricle wall.

Figure 37 B shows another embodiment of this aspect of device, is wherein attached to stablizing of upper support element 1540 Change element 1560a than the much shorter shown in Figure 37 A, and to the lower surface of valve annulus 1600 (rather than the laterally inner side to ventricle Wall) apply stability force.During implanting, stabilisation element enters the position less than valve annulus, thus valve annulus " captures (trap) " between described stabilisation element and upper support element itself.

This embodiment be further variations on display in Figure 37 C.This change case different from the embodiment shown in Figure 37 B it Place is that upper support element 1540 is equipped with both upper stabilizer element (1560s) and lower stabilizer element (1560). During implanting patient, valve support device is operating as so that valve annulus 1600 " capture " is in upper stabilizer element and bottom Between stabilisation element.In each change case of this embodiment, by mechanical closing mechanism, air bag expansion machine can be passed through Structure makes short stabilisation element in place, or the most described stabilisation element can be self expandable.

Figure 38 shows the replacement design of the valve support of the present invention, and it comprises additionally in horizontally disposed annular stabilisation Element 1660, it is between upper support element 1640 and lower support element (not shown).Elastic component 1620 is by top Support component (1640) and described extra ring support member (1660) are connected with each other.Valve annulus 1600 can thus capture or pressed from both sides Pinch between which (as shown by arrows).This design can use in the case of any additional stabilization element or with institute above Any stabilisation device embodiments stated is applied in combination.

In a further embodiment, as shown in Figure 39 A, valve support device, it can be seen that be one time viewed from above To elastic stability element 1958, the every side of upper support element 1960 there is one.These stabilisation elements can be with raw Thing adaptability metal manufactures, and includes, but is not limited to Nitinol, cobalt and rustless steel, and is fabricated to the form of spring-like lug, its The elastic force being applied in ventricle wall by device is allowed to be distributed on big surface area, in order to make the local of heart tissue Minimum pressure, so that the minimizing risk that the heart tissue cells caused due to high-grade mechanical stress is downright bad.Can So that the side view in this embodiment of device to be seen the structure of tab-like stabilisation element 1958, as shown in Figure 39 B.As from this It can be seen that each lug preferably (can such as be used terylene, PTFE by biocompatibility fabric or screen cloth 1962 in a little accompanying drawings Deng manufacture) cover, its key function contributes to distribution power, as it was previously stated, and also promote heart tissue grow on device, by This improves the attachment of itself and heart wall.The concrete advantage using this kind of stabilisation element is that it makes upper support element Bottom left atrium, (stabilisation element extrudes from ventricular side and upper support element is from the heart the most substantially to extrude valve annulus Side, room extrudes), it is consequently formed " stopper ", it will prevent heart perivalvular leakage, even big than the diameter of artificial valve at valve annulus In the case of be also such, as long as upper support element is than valve annulus more greatly.In this embodiment, upper support element is permissible Assembling by one or more this kind of stabilisation elements, described stabilisation element can around the periphery of described support component uniformly or not It is uniformly distributed.The exemplary dimensions of this tab-like stabilisation element is as follows: width 2-20mm；With long 2-20mm.However, it should be understood that The purpose of these values is only exemplary, and the stabilisation element of size more greater or lesser than this scope is also included within the model of the present invention In enclosing.

As above, stabilisation element need not provide with the form of unbroken loop, it is possible to have part ring or bending are thin Long-armed form.The various examples of the type of a rear stabilisation element show in Figure 40-48.Including two this kind of anchoring wings The example of the supporting construction of thing shows in Figure 40.(it should be understood that this accompanying drawing and all Like show similar installation Top view, it is therefore an objective to construct with the pre-crimped of described device and show described device).Supporting construction 1010 in this example includes circle Shape support ring 1012, described circular support ring is equipped with element 1014, and described element allows the inner edge radial direction of described ring It is resiliently deformed (the replacing valve thereby assisting in ring and any size accurately adapts to).Device also includes two anchoring wings 1016, its base component 1018 is continuous with ring itself.It practice, in a most preferred embodiment, wing by with ring itself Identical discoid pieces cuts out.Finally, described wing each also there is aperture 1019, described keyhole formation is near it is remote End, the purpose in described hole contributes to operator's gripping device during implementing, as described in detail below.

Figure 41 show its from deployment catheter discharge after and anchoring wing 1016 be expanded to its open, Same valve support device after work structuring.

Figure 42 shows the valve support device of Figure 40 and 41, and this is to implant in the region of heart valve annulus 1030 at it (in order to understand that lower support element is not shown) after heart.Thus, it is possible to find out that anchoring wing 1032 is along primary two points The commissure of lobe 1034 is arranged, thus the existence of support means is not disturbed in this stage function mutually with described native valve. It should be noted that anchoring wing 1032 extrudes the ventricular organization contacted, so that described tissue slightly radially outward displacement. (due to the restriction of accompanying drawing, this displacement is invisible in Figure 42).

The different embodiments of this aspect of the present invention show in Figure 43, where it can be seen that each anchoring wing has The base segments 1040 amplified.Can see in the enlarged side view of this device further, in its expanded configuration (Figure 44 institute Show) under, expansion base segments (being shown as 1050) contribute to anchor wing just at described wing away from ring supporting construction Mechanical strength at the point of bending.

In another embodiment, as shown in figure 45, anchoring wing 1060 is more wider, along institute than the wing in accompanying drawing before State each whole length (from base segments 1062 to far-end 1064) of wing and keep the width of this increase.Due to it more Big width, in this accompanying drawing, bigger stability force can be delivered to ventricular organization by the anchoring wing of the embodiment of display.This Anchor force is also distributed on the more high surface area of heart by bigger wing, because power distribution reduces in cardiac muscular tissue Local stress, and this is the most favourable, because it prevents from damaging the heavily stressed of tissue.

Slightly different method shows in figures 4-6 can, and wherein support means includes four anchoring wings, two short limb shapes Thing 1070 and two long wings 1072, they are arranged so that a short wing and a long wing are located side by side at On every side of device.One advantage of this embodiment of support means is short wing on each side and longer wing Both form compensation mechanism, thus (the longest wing) in described wing on each side does not makes with ventricle wall In the case of people contacts satisfactorily, another wing (short wing) can satisfied with ventricle wall contact.

In at present described and Figure 40 to all each embodiment shown in 46, anchoring wing be formed as with and support ring The solid structure that identical discoid pieces itself cuts out.In the method replaced, as shown in the photo of Figure 47, (lower support element is not Illustrate), wing 1080 is configured to Unclosing structure.First this kind of wing such as can be by cutting out width from support ring discoid pieces Wing and remove material the most further and formed, thus one or more tinsel is maintained in wing.Two so Silk 1082 display is in the design shown in Figure 47.One advantage of the method be can construct this broader anchoring wing (by This can apply stability force to the larger area of ventricle wall), and do not increase the volume or weight of described wing.As it was previously stated, this Plant bigger wing also anchor force to be distributed on the more high surface area of heart, because power distribution reduces in cardiac muscular tissue Local stress, and this is the most favourable, because it prevents from damaging the heavily stressed of tissue.

Further embodiment shows in the photographic picture of Figure 48.The device shown in this accompanying drawing includes having opens knot The wing of structure, described wing can exist with two kinds of different configurations, and these two kinds of different configurations are: (a) is elongated, minor diameter structure Make, formed during its curling during inserting the device in deployment catheter；(b) the wider form shortened, such as Figure 48 Shown in.As shown in drawings, the anchoring wing 1090 of this specific embodiment, under its work structuring, there is wide diamond shape, And thus can apply relatively high stabilisation power on the region near the ventricle wall of support means.It should be noted that if having this The wing planting increase width is formed as solid structure, then be very difficult to device is crimped onto its storing shunk structure.Thus, The skeletal structure using this type shown in the drawings is very favorable, because once support means has been launched, and a combination thereof Mechanical advantage for long narrow wing and the short wide wing of catherization.

Wing can fully or only be covered by fabric or other covering materials at its far-end.Highly preferred at one In embodiment, the covering material (such as biocompatibility terylene) of use will allow to grow heart tissue wherein.With this side Formula, can additionally anchor to heart tissue by wing.

Device can be formed by the cutting of Nitinol discoid pieces, and described discoid pieces is used for forming support means.This ring with By going through heat treatment (such as at a temperature of 500-600 degree Celsius), wing bends in expectation operating position, thus from putting After putting device release, wing will take the shape memory position that it is new.

In some preferred embodiments, wing has the aperture drilling its extreme distal end, in order to from deployment catheter Deenergized period allows operator easily to grasp support means with narrow end tool or silk, thereby assists in and is moved by described device To operating position.

In some embodiments of the invention, the valve support device carefully selecting correct size will allow to send at device Support means described in period is self contained in the region of valve annulus after self expandable, as described below.But, at other In the case of, the valve support device of the present invention farther includes one or more heart tissue Anchoring devices or mechanism (is connected to Support component and/or bridge member), for described valve support is anchored to heart tissue securely.In this aspect one In individual embodiment, heart Anchoring devices includes multiple spiral type or hook-shaped anchoring piece.The example of this kind of Anchoring devices shows at figure In 49, which show in the guiding conduit 710 in the valve support device for putting the present invention.Storing shown in the figure Under the stage of process (it is described in more detail below), two support components 720 and 740 and bridge member self expandable arrive it Work structuring.It will be seen that upper support element fitted to be has two spiral heart attachment anchoring pieces 760, its point Sharp free end is towards side.The base portion (i.e. medial ends) of anchoring piece is connected to control silk thread 780, and described control silk thread is upwards And closely through guiding conduit 710, finally leave the health of patient and terminate at near-end control station.Once valve support dress Put and be operated into desired locations (as shown in drawings), the control silk that the most spiral anchoring piece 760 is operated by operator The near-end of line and rotate, thus insert heart tissue and thus valve support device be anchored at its operating position securely.

It should be noted that Figure 49 only show an exemplary design for heart tissue anchoring piece, and other designs many Also possible, and be included within the scope of the present invention.Thus, in another embodiment, hook-shaped anchoring piece is along valve support Be attached at each point of apparatus surface, attachment on a support element, on bridge member or on both.This embodiment shows at Figure 50 In, which show typical valve support device 700, bridge structures on the surface and two that distributed multiple hook-shaped anchoring piece 770 Part 750, above includes whereabouts support component 740.(nine such anchoring pieces show in the accompanying drawings).

In some cases, it is advantageous to, during valve support device inserts health, heart tissue anchoring piece uses and closes The inoperative structure closed, in order to avoid patient tissue causing wound and avoiding anchoring too early (such as in incorrect position Put place).Subsequently, when described device is correctly positioned, anchoring piece by the inoperative tectonic movement that closes from it to beating The position worked opened.There is the various ways performing this kind of embodiment.Thus, in the first embodiment, heart attachment The part that casts anchor be configured with two or more towards after from Kaiyuan City's end arms.During inserting and implanting, distal arm is little by one The absorbable suture material of circle is maintained at closed structure.Subsequently, week certain time after described attachment means enters ventricular organization After phase (such as between a few hours and several weeks), described suture material dissolves, and thus allows distal arm to use it to open structure. This embodiment shows at Figure 51 A and 51B: in Figure 51 A, and far-end anchor arm 790 is illustrated by suture material 800 and is kept In its make position.In Figure 51 B, the Len req time passes by (after the insertion) and suture material has dissolved, and releases Put far-end anchor arm and allow them separately to stretch in heart tissue, thus increase by described anchoring piece provide to exiting (withdrawal) resistance.

In further this kind of embodiment, manufacturing anchoring hook with shape-memory material, such as biocompatibility Ni-Ti is closed Gold (such as Nitinol).During inserting, anchoring piece is in its closed structure, but after the implantation process, recovers with them Its original shape, the temperature rising experienced during inserting patient body causes anchoring piece to open,.

In further this kind of embodiment as shown in Figure 52 A and 52B, anchoring hook be capped element 820 (such as sleeve or Pipeline component) protection, described cladding element is by having limited flexible material manufacture, such as PET, nylon and similar biology Adaptability plastics.After operator correct position the most implanted to valve support device pleases oneself, it is attached to cover The control element 840 (such as controlling silk) of element is pulled, so that they are by guiding conduit to exit, thus allows anchoring Hook freely takes it open structure and insert heart tissue.In the design shown in Figure 52 A, each anchoring piece is by their own Covering protection, and in Figure 52 B, the protection of single cladding element is attached to all anchoring pieces of upper support element and (does not shows Go out).

Figure 53 A and 53B shows the further embodiment of this aspect of the present invention.Thus Figure 13 A shows and passes through trocar sheath 890 anchoring pieces 860 having barb being attached to support component 880 are maintained at inoperative straight configuration, and described trocar sheath is also For protecting the tissue of patient to preserve from during the insertion of valve support device and implantation.Implanting at desired locations it After, as shown in figure 53b, trocar sheath 890 is pulled away from anchoring piece 860c (such as by pulling control silk), and it takes it now " naturally " curved configuration, transfer of shapes during this period, described anchoring piece thrusts heart tissue now (such as the alphabetical A in accompanying drawing Shown in).With suitable anchoring piece applicable shapes memory material in this embodiment or with the most resilient material manufacture, such as Nitinol, cobalt-base alloys and the rustless steel of spring temper (spring-tempered).Generally, this kind of anchoring piece has about The diameter of the moderate-length of 0.2mm to 1mm, and the length of about 2 to about 10mm.Suitably trocar sheath can use biological adaptation Property polymers manufacturing, the nylon such as woven and PET, to have the tolerance allowing tightly to be assembled on anchoring piece.

It should be noted that heart tissue anchoring piece as above can be used in some cases by the valve support of the present invention Device be attached to anatomy valve leaflet and chordae tendineae (except or replace attaching the device to internal ventricle wall).Therefore, originally Invention also includes the heart tissue anchoring piece of additional type, it is characterised in that have multiple anchoring silk thread, the plurality of anchoring silk Line is advantageously involved in valve leaflet and chordae tendineae.This kind of anchor log is particularly suited for being attached lower support element and bridge member To above-mentioned anatomical structure.

In a further embodiment, heart tissue anchoring piece can provide with the form of Small clamp (be similar to for Closing the vascular folder of blood vessel in surgical procedures, it is well known in the art).The example using this embodiment shows at figure In 54, wherein clip 952 for being attached to valve annulus 956 by upper support element.This kind of clip can be used for propping up top Support element is attached to atrial wall tissue and/or anatomical valve leaflet.In a particularly preferred embodiment, clip attachment Tissue in Delta Region (a kind of anatomical regions), on mitral two opposition sides, it has more multifilament group Knit, and therefore it can provide firm foundations for anchoring described valve support device.

In another embodiment (not shown), clip can be top or lower loop or the integrated part of bridgeware.This can To realize by the claw of clip is attached to valve support device, and second in claw is freely, with Plastic deformation and anchor to tissue.

In the case of some that can use in conjunction with the valve support device of the present invention change valve, by expansion more The radially outer power changing valve applying be enough to stably be maintained at by described valve the internal cavities of described valve support device In.But, in some cases, especially when self expandable changes valve implantation, the radial force applied by the valve of expansion It is insufficient to assure that it can resist all physiological power applied in all stages of cardiac cycle.In this case, The bridge member of valve support device and/or support component may further include valve bonding part.In one embodiment, A series of meander-like folding parts that valve bonding part can be included in the deepest region of central authorities of bridge member or fold.These Folding part or fold interact with pole or other architectural features of replacing valve, so that described valve is stable at valve In support means.

In another embodiment, valve bonded device includes towards anchoring piece that is interior or that face out, its objective is and change The outer struts of valve engages, so that described valve is stable in support means.

Figure 55 shows the valve support device of the present invention, and it includes two above-described embodiments of valve bonded device.By This, it can be seen that the middle body of bridge member 850 is folded into a series of fold 860.Additionally, described bridge member also sets up Have towards interior anchoring piece 870 and the anchoring piece 880 faced out.

Figure 56 A and 56B shows the another embodiment of valve bonded device, and it is attached to the Example support unit of the present invention Part 900.Thus, in Figure 56 A, four of soft biocompatible material (such as biocompatibility fabric, silicon, PET etc.) 920i Short length thereof is attached to the inner surface of element 900.Replacing valve bracket expansion in the inner space of valve support device Time, soft material passes between valve bracket pole, is consequently formed joint " tooth ", and it is used for so that changing valve support device Assembly is stable.Figure 56 B shows very similar quaternate bonded device 920t, and it is by soft biocompatible material shape Become.But, in this case, soft material is to support around (partially or even wholly) in four positions shown in the drawings The form of the tubular sleeve of element 900 provides.

Fig. 2 A shows exemplary transporter and shrinks the mitral valve support member put under structure.Transporter 30 wraps Include the Actuation portion 35 with actuator 34.Transporter 30 also includes that slender body 32, described slender body are fixed to actuate Part 35.Transporter 30 also includes the guidewire lumen 42 coupling Rule parts (luer) 38, and wherein inner chamber 42 is suitable at seal wire 40 are distally advanced (see Fig. 2 B), to allow transporter 30 proceed to the target location in main body.Dotted line left side transporter 30 Part can be considered as the proximal part of transporter 30, it remains in outside patient at least partially in operation process Portion, it is provided that the user operation to Actuation portion 35.The part on the right of dotted line of device can be considered as distal portions, and generally It it is considered as the part of the transporter being suitable to advance through patient in operation process.Actuator portion 35 includes actuator 34, described actuator is suitable to the motion being actuated to control slender body 32.Specifically, actuating of actuator 34 controls elongated Body 32 is relative to inner chamber 42 and the motion of valve support 44.In Figures 2 A and 2 B, the Spin Control slender body of actuator 34 The displacement to axial of 32, but the actuator of any other suitable type can be used and is incorporated in system, thin to control The axial displacement of long body 32.Inner chamber 42 axially can be moved relative to slender body 32 by the axially-movable of inner chamber 42 near-end Position.Transporter 30 also includes device coupling member 36, and it extends beyond the near-end of the proximal part of device 30, and also carefully Long body 32 is radially inwardly directed to remote extension and is still guiding beyond inner chamber 42.Device coupling member 36 during launching Remote area is releasably secured to valve support 44 (as shown in Figure 2 A and 2B), can from valve support 44 but be also suitably for Control ground release, valve support to be discharged from transporter.Coupling member 36 can be by being actuated to trouble by its proximal part It is actuated beyond person, to control the motion of valve support 44.During valve support 44 is in slender body 32 in fig. 2 Shrink put structure and be arranged on guide inner chamber 42 outside.In putting structure, the annular section 45 of valve support 44 Bridge member 47 retracted downward (only show a bridge member).When shrinking, the most each semi-circular support member 45 is all Retracted downward and there is C-shaped configuration, have ratio in expanded configuration (the storing structure of valve support as that shown in fig. 2 c) time Tighter curved configuration (i.e. there is the part of less radius of curvature).In putting structure, bridge member 47 presents ratio in expansion Structure more straight in structure.As described in detail later, annular brace element can be biased at some location bendings, so that being subject to During power and in any contraction process again that may need, it shrinks easily.The axial location shrinking valve support passes through Coupling member 36 controls.Fig. 2 B shows the part of the process for discharging valve support 44 from transporter 30, and (it is thin Joint describes later).Actuating of actuator 34, as shown in the rotation of actuator 34 so that slender body 3232 is proximally Return.Guiding inner chamber 42 can be held in place or be distally advanced and slender body 32 is retired.Slender body 32 and coupling member Relative motion between 36 (valve support 44 is attached to coupling member 36) allow valve support 44 slender body 32 to Expand during proximal movement.In fig. 2b, the first valve support element (with the sub-fraction of bridge member 47) expansion.Elongated The permission valve support 44 of persistently returning of body is fully expanded, and is still connected to coupling member 36.

Fig. 2 C shows the replacement perspective view of transporter 30, it is shown that two bridge members 47.But, in fig. 2 c, When shrinking in slender body 32 in putting structure, support component 45 is suitable to become in the substantially axial end away from bridge member Shape.In the embodiment of Fig. 2 A-2C, slender body 32 such as can be but not limited to conduit, and its example is known.Actuation portion Points 35 such as but not limited to being Touhy Borst, and it allows actuator 34 to rotate, to control the axially-movable of slender body 32. Guide inner chamber 42 such as can be but not limited to the inner chamber of corrugated steel strengthening, to allow to have while advancing through vascular system There are enough pliabilities.Guide what inner chamber 42 can also is that any other type properly to guide inner chamber.

Get involved in Bicuspid valve or other chamber valves will preferably realize (passing through skin by the vascular system percutaneous of patient Get involved).It is well known in the art that percutaneous gets involved in vascular system position at a distance.Depend on the point that vascular is got involved, Bicuspid valve method Can be direct motion and need by entering left atrium through septum interatriale cordis.Alternatively, can be inverse to mitral method Row, left ventricle is entered in this case through aortic valve.Alternatively, Bicuspid valve can be got involved through the apex of the heart, in ability Territory is known.By the antegrade approach of septum interatriale cordis and other suitable interventional method details can in United States Patent (USP) No.7,753, Finding in 923, this patent was submitted on August 25th, 2004, and its content is incorporated herein by reference.

Although supporting construction herein is described generally as being for changing the support changing valve at mitral valve ring Part, but it can be placed to desired locations, to support other cardiac valve changed, such as, changes tricuspid valve, changes lung Valve, and change aortic valve.

Fig. 3 A-3E shows the sectional view of heart H, it is shown that launch the example of valve support in primary Bicuspid valve MV Property method.Use known method by thigh blood vessel, IVC, right atrium, cross septum interatriale cordis S and entrance left atrium LA and get involved Have been able to realize to Bicuspid valve.The exemplary details of this method can be such as but not limited in United States Patent (USP) No 7,753,923 In find.As shown in Figure 3A, every S in guiding conduit 50 (such as 18F guides conduit) to advance through on seal wire 52, to carry For to mitral intervention.Seal wire 52 is already advanced through primary Bicuspid valve and enters left ventricle, to allow transporter leading Advance on silk 52 and enter and primary Bicuspid valve obtains position.Alternatively, guide conduit 50 can advance in place on seal wire 52, and lead Silk 52 can be subsequently removed.Transporter can simply then advance through guiding conduit 50 and not use seal wire 52.But, lead Silk 52 can be preferably in place on the left side, to allow the cardiac valve of the replacing put subsequently to advance on seal wire 52.In figure 3b, Have valve support be contracted in transporter 54 therein on seal wire 52 advance and by guide conduit 50, and advance To guiding beyond the far-end of conduit 50.Transporter 54 advances through primary mitral lobule L, thus slender body 55 is remote End is arranged in left ventricular LV, as shown in Figure 3 B.

As shown in Figure 3 C, slender body 55 is proximally return relative to valve support subsequently, by valve support from carefully Long body 55 discharges (such as using the such actuator of actuator 34, shown in Fig. 2 A-2C).In this embodiment, valve support Part resilient material manufacture, such as Nitinol, and because slender body 55 must be return and start self expandable.In fig. 3 c, One support component 58 self expandable is to the circular structure of expansion, as directed.When support component 58 is expanded, it is at mitral valve ring The heart tissue of ventricle is engaged, by itself against fixing below plane.Support component 58 is preferentially positioned at sub-annular space, with Minimum or do not damage and fix against mastoid process tendon, the most do not interfere its function.Support component 58 is preferably to far-end foot Enough expand, thus primary mitral valve lobule also can function after support component 58 is expanded.As it has been described above, at some In embodiment, supported underneath element has the diameter less than upper support element, the internipple distance measured from main body with coupling From.Less relative diameter is that supported underneath element provides opposing mastoid process tendon and do not makes their ability.Mastoid process tendon is in mastoid process One end of flesh and being attached at the other end of native valve leaflets, and allow mastoid process tendon or Papillary muscle displacement will prevent native valve leaflets Correct Guan Bi so that cause adverse current during valve support is expanded.Supported underneath element is the most in position and does not interfere The function of native valve leaflets.Referring briefly to Fig. 7, it is in place that exemplary valve support member shows that I expands.Supported underneath element 130 are shown as having the diameter less than upper support element 126.But support component 130 is against mastoid process tendon 124 does not allow them Displacement, and do not disturb with Papillary muscle 122 and mastoid process tendon 124.Support component 130 is expanded in sub-annular space, and Support component 126 is expanded in left atrium LA.Although embodiments shown herein show supported underneath element by mastoid process tendon and/ Or Papillary muscle displacement, but purpose is underlying support to be correctly sized thus it is expanded in the way of shown in Fig. 7.

Referring back to Fig. 3 C, slender body 55 is proximally return relative to a part for bridge member 60, it is allowed to bridge The part expansion of connection member 60.If necessary this some support component 58 in slender body 55 in this process can be received again Contracting.The location of valve support can use known visualization technique (such as fluorescent technique, or any other imaging technique, if Necessary) and visualize, and if it is determined that support component 58 is incorrectly positioned, then slender body 55 can relative to valve support to Distal advancement, coupling member 64 can be return relative to slender body 55, or combination can perform to allow support component 58 extremely A few part is shunk in slender body 55 again.Valve support can be relocated subsequently, and support component 58 can be subsequently Further expansion is with the most in position at desired anatomical position or space.

As shown in Figure 3 D, slender body 55 continue proximally (not shown in Fig. 3 D) return permission the second support component 62 from Expansion, the sidewall itself against the atrium above mitral valve ring is fixed.In certain embodiments, the second support component includes one Individual or multiple retaining elements, such as fixture, agnail, fixture etc., contribute to fixing the second support component against heart tissue, Or be adapted to pierce through entering heart tissue, so that support component is fixed to heart tissue.One or more retaining elements, if used Then can arrange around support component periphery.They can present the contraction for delivery system or storing structure, but from putting system It is deployed to expansion or anchoring structure during system release.Such as, retaining element can be elastomeric material, and its self expandable is to anchoring structure Make.Alternatively, retaining element can be actuated, but so that they are reconfigured to fixture construction., in certain embodiments, one or Multiple retaining elements are unsuitable for changing structure.In order to clear, mitral valve lobule is not shown at Fig. 3 D.Coupling member 64 is (at figure In 3D, only one is visible) the most controllably it is fixed to the second support component 62.Support component 62 can exist at this point in this process In slender body 55 to return again shrink.This can be happened as stated above relative to support component 58.In certain embodiments, prop up Support element 62 may be adapted to priority bending (putting structure towards it to shrink) near the fixing point of coupling member 64 or at point.If Determining that support component 62 should shrink in slender body 52 again, the most proximally facing power can be applied to coupling member 64, thus Support component 62 applies.If support component 62 is suitable to preferentially fixing at coupling member location bending, then power will propped up Support is suitable to the position of priority bending and applies.Permission support component 62 more easily and more effectively towards its contracted configurations is become by this Shape.Once support component 62 shrinks in slender body 55, and the continuing to return of coupling member 64 can make support component 58 also receive Contracting.Support component 58 may be adapted at some position priority bendings as support component 62 so that puts structure towards it Deformation is easily.

What the bridge member 60 on support component extended therefrom position is separated from each other substantially 180 degree, is similar to primary Substantially 180 degree at valve leaflet abutment separate.In the expanded configuration shown in Fig. 3 D, the bridge member on support component is from it The position of upper extension is substantially preferably positioned as the end of closing line between two native valve valve leaflets.I.e. on support component The connecting line of point that extends therefrom of bridge member preferential (although be not must) be directed at native valve leaflets closing line.One Individual or two support components can have the impermeable labelling of radiation, just to contribute to valve support correct orientation in these positions Position.By allowing bridge member be positioned at these positions relative to native valve leaflets, even it is deployed into completely in valve support Ground expanded configuration, as shown in Figure 3 D, bridge member the most not in implantation process function with native valve leaflets disturb mutually (or extremely Few minimally interference).Because native valve leaflets can during this part of this process function, so the time be not Key factor during valve support expansion.

Although supporting construction is commonly described as because of two bridging elements herein, but supporting construction can have than setting Two more bridging elements of bridging element in any structure around supporting construction.

It follows that guiding elements 56 is return from patient, make seal wire 52, guiding conduit 50 and slender body 55 in place, such as figure Shown in 3E.Guide conduit 50 and seal wire 52 can provide mitral intervention, to allow replacing Bicuspid valve to be fixed to valve support Part, described valve support is the most stretched and is fixed in native valve.

Fig. 4 A-4D shows that the valvular of exemplary replacing is put subsequently and expand.In Figure 4 A, there is air bag 70 Balloon catheter and replacing valve 72 thereon advanced on seal wire 52 and in guiding conduit 50, proceeded to expansion Position radially shown in valve support.Generally, change valve 72 include expandable stent in this example embodiment and consolidate therewith Fixed replacing valve leaflet, replacing valve advances up to it and is positioned radially within the valve bonding part 61 of bridge member.One Denier is changed valve and is determined being in and crosses the optimum position of Atrial-ventricular line and (such as use visualization technique, such as heart echo Figure), changing valve can be expanded.

As shown in Figure 4 B, air bag 70 is not expanded by filling it by expansion fluid, and this process is well known in the art.Gas The expansion of capsule 70 makes to change the expandable stent part expansion of valve.The expansion of support is on the bridge member of valve support Apply power radially outward so that they they expansions (or, outward direction deformation in a generally radial direction).At stent-expansion Time, native valve leaflets is outwardly directed to valve annulus and promotes by support.When stent-expansion, by the support that timbering material limits Hole be suitable to other surface character of valve bonding part with bridge member or protuberance engages, to be fixed by expandable stent To bridge member.The radially-inwardly bias of bridge member additionally aids incites somebody to action by applying radially inner bed knife on support Change valve to be fixed in valve support.Support applies power radially outward, and two-way interaction on bridge member To allow replacing valve in position, prevent replacing valve axially displaced and shrink.It addition, bridge member may be adapted in expansion more Change and valve process of expansion presents preferential expanded configuration (shown in such as Fig. 4 B).Such as, bridge member may be adapted to have curved Break 75, the priority bending when this inflection point bridge member will be expanded, prevent two supporting members from changing valve processs of expansion then Migrate axially away from one another.Valve also can be changed for supporting construction is fixing by auxiliary phase in inflection point 75.

Change valve the most stretched and in position after, air bag 70 is exitted and recalls from patient together with seal wire, as Shown in Fig. 4 C.Once air bag deflation, the valvular valve leaflet L of replacing starts function.Show that three valves are little Leaf, which show known replacing aortic valve, only United States Patent (USP) No7, the example described in 585,321, this patent Submitting on May 27th, 2005, it can use to replace primary Bicuspid valve in this example process.

Although the cardiac valve that balloon expandable is changed is it has been shown that but the cardiac valve changed also can self expandable.

Once change valve in position in valve support, then coupling member 64 disengages from support component 62.At this In exemplary embodiment, the far-end of coupling member 64 has screw thread, and it is suitable to and the engagement threaded in support component 62.Couple The rotation of component 64 makes coupling member 64 untie spiral from support component 62, thus by coupling member 64 from supporting 62 disengagings. Guide conduit 50 to remove from patient subsequently, make implant in place, as shown in Figure 4 D.

As it has been described above, Bicuspid valve can be got involved via transapical approach, or the summit through heart.In such method, connection Connection member 64 will be fixed to supported underneath element 58 rather than upper support element 62, as shown in this embodiment.Coupling member 64 can by such as herein described same in the way of actuate.

Fig. 5 A-5D illustrates exemplary transporter and is in the mitral valve support member putting structure wherein.Transmit dress Put and be similar to mitral valve support member shown in the embodiment of Fig. 2 A-2C.Transporter 80 includes haemostatic valve 82, described hemostasis Valve includes rotating convex Luer lock 81 and recessed Rule side ports 83.Transporter 80 also includes the slender body being fixed to actuator 85 84, wherein actuator 85 is suitable to rotate to control the axially-movable of slender body 84.Device 100 be contracted in slender body 84 and Arrange radially outwardly relative to inner chamber 86.Transporter 80 also includes guidewire lumen 86, and it is suitable to receive at it seal wire 90 In, it being connected to Rule parts 88, it is adapted to slender body 84 axially-movable.Coupling member 92 is reversibly fixed to valve Support member 100, as described in the above-described embodiments.Other details of transporter 80 can be with the phase described in above-described embodiment With.

In figure 5b, the actuating so that slender body 84 is proximally return relative to valve support 100 of actuator 85.This The far-end support component 101 making valve support 100 starts self expandable to against organizing (in order to understand that anatomical structure does not shows Go out) expansion, the embodiment of such as Fig. 3 A-3E.Haemostatic valve 82 alternately or additionally is pulled proximally (in Fig. 5 B Shown in arrow) so that slender body 84 is return relative to valve support 100.Additionally or alternatively, guiding inner chamber 86 can phase (as shown in Fig. 5 B arrow) is distally advanced for slender body 84.The motion of these types can promote or contribute to valve support The expansion of part.

As shown in Figure 5 C, the bridge member 102 of valve support 100 continues through the fortune of opposite proximal end of slender body 84 Move and expand.This can obtain proximal movement by slender body and perform (as shown by arrows), by allowing inner chamber 86 be distally advanced Perform, or performed by both modes.The relative motion that slender body 84 continues finally makes the second support component 103 expand To deployment configuration, as shown in Figure 5 D.When the second support component 103 self expandable, coupling member 92 can be together with support component 103 Extend radially outward.

Once valve support is confirmed as positioning in place, then guide inner chamber 92 can be removed to allow the heart valve changed Film positions in valve support, and its example shows at Fig. 4 A-4D.

Fig. 6 shows the sectional view of a valve support 110, including first support component the 114, second support component 116, bridge member 118, and connection element 112, they are illustrated as screwed hole and are suitable to be securely joined with the band of coupling member Threaded portion, its example is described above.Fig. 8 A and 8B shows the alternative embodiment of valve support.Valve support 200 is wrapped Include the parts relaxed valve leaks.Except support component 202 and 204 and bridge member 206 and 208, valve support 200 is wrapped Include one or more 210 and 212.Fin extends the coverage of valve support system, and contributes to relaxing and let out valve Leakage, the function of the mud guard being similar on automobile.During launching, exemplary airfoil 210 and 212 around or against upper support Element 202 is adjacent to, and as shown in Figure 8 B, and when launching from conduit, fin is expanded or extends to the structure shown in Fig. 8 A (in order to clearly Chu, native valve is not shown).Fin can manufacture by pliability biocompatible material, the most various polymer.Fin can pass through Any suitable mechanism and be fixed to valve support, such as by fin being sewn onto support component, or be sewn onto coating The material of lid, and use bridge member to prevent suture material from shifting.

Upon deployment, in certain embodiments, fin is arranged on above valve annulus and the side of support component up On, it can not extend to atrial walls.The less millimeter of coverage of this expansible valve support system, reduces lobe Film leaks.Alternatively, in certain embodiments, wherein support component is bigger, and fin is prompted to against atrial tissue.In this use In, when valve support system is in place, fin is used as extra sealing member.Therefore one or more fins can be valve support The parts of part system, it reduces valve leaks and/or is used as extra sealing member.

As described above, in some other embodiments, it is attached to one of support component or both knit by use Thing curtain prevents perivalvular leakage, is preferably attached in use will become that the support component above in described element.Thus, The side view of the Exemplary upper ring 2001 (upper support element) of the 57 circular valves support members showing the present invention, is shown as On mitral valve ring 2000 in place, and include the fabric curtain 2002 being attached to the inner circumferential of ring.Curtain in the inner circumferential of top loop Unique location has multiple special advantage: the function of curtain is " valve leaflet " between mitral valve ring and top loop, thus exists During heart contraction, fluid is when ventricle flows out, and curtain is pushed up towards valve annulus by the flowing of blood, and this motion improves top loop And the sealing between valve annulus, (shown in the arrow in Figure 57), thus it is essentially acted as the valve between ring and valve annulus, And it is therefore prevented from perivalvular leakage.

Figure 58 shows the side of the Exemplary upper ring 2001 (upper support element) of the circular valves support member of the present invention View, is shown as in place on mitral valve ring 2000, and show schematically show the fabric curtain 2003 of the periphery being attached to ring. Curtain position on the exterior section of top loop allows its potted component being used as between described ring and valve annulus (to be similar to seal The function of " o " type ring), thus ring near and when being attached to the region of valve annulus, curtain is used for so that valve annulus seals and prevents Perivalvular leakage.In some embodiments of the invention, the length of curtain makes the edge of curtain extend into left ventricle (as shown in Figure 58). This is favourable, because the curtain element of this growth improves the sealing between the perimeter of ring and mitral valve ring and anti-stopping leak Leakage.

Exemplary materials for the curtain of the present invention is any kind of biocompatibility fabric, such as terylene, ePTFE. The exemplary dimensions of the curtain of the present invention is 2mm-20mm length and 2mm-60mm width, thus the part of cover ring or whole weeks of ring Edge.

Figure 59 shows the perspective view of the Exemplary upper ring 2001 (upper support element) of the valve support of the present invention, Show multiple fabric curtain 2004 of the present invention.Showing five this separate curtains, remaining curtain is the most not shown.Excellent Choosing, has little overlap between curtain, thus does not leak between neighbouring curtain.

Figure 60 shows the further design of the fabric of the curtain for the present invention.Biocompatibility used as shown in the figure by curtain 2010 Fabric manufactures.In order to give stable form (because making it have reservation shape), in its manufacture process, biological adaptation to curtain Property tinsel 2011 is sewn in the material of curtain.Exemplary materials for this silk is rustless steel or Nitinol.Tinsel can Shape according to pre-provisioning request, and maintain this shape due to the mechanical performance of silk.The advantage of this pre-figuration is this shape May be designed such that it improves the sealing between ring and valve annulus, thus flow and curtain will be made to tend to seal valve annulus, Allow curtain move near valve annulus, and prevent perivalvular leakage.

Although some embodiments are described herein, but it will be understood by those skilled in the art that such embodiment is the most logical The mode crossing example provides.Those skilled in the art are appreciated that many change case, change and replace and can make without deviating from this Invention.It should be understood that the various replacements to embodiment as herein described may be used for implementing the present invention.

Claims (16)

1. a heart valve support part, is suitable to endovascular and is put into cardiac valve, including:

First and second support components, each of which storing structure with contraction and deployment configuration；

At least two of which bridge member extends to the second support component from the first support component, and described bridge member has storing Structure and deployment configuration, wherein said bridge member radially-inwardly prolongs under its deployment configuration or from the first and second support components Stretch, or longitudinal extension and between described first and second support components, there is no any appreciable radial buckling, i.e. without Auxiliary is un-flexed so that bridge member during eye-observation is the most straight；

At least one of wherein said first and second support components has neighboring, supports unit being in described first and second Time under the deployment configuration of at least one of part, described neighboring is perfect rigidity；

And at least some of radially elastically deformable of the inner rim of at least one of which support component.

2. heart valve support part as claimed in claim 1, wherein the first and second bridge members support from first and second Element relative to each other extends 180 degree.

3. heart valve support part as claimed in claim 1, wherein at least one in the first and second support components has Annular shape.

4. heart valve support part as claimed in claim 1, at least one of which support component has under its deployment configuration Difference (Rd) between the form of planar annular ring, and outer radius and the inner radial of wherein said planar annular ring is at 1-14mm In the range of.

5. heart valve support part as claimed in claim 4, between difference (Rd) and the thickness of wherein said planar annular ring Ratio is 10:1 to 20:1.

6. heart valve support part as claimed in claim 4, wherein the inside diameter of planar annular ring is in the scope of 23-29mm In and its outer dia in the range of 30-50mm.

7. heart valve support part as claimed in claim 4, wherein the thickness of planar annular ring is in the scope of 0.25-0.6mm In.

8. heart valve support part as claimed in claim 1, wherein support means farther includes one or more extension, It is attached to bridge member or is attached to one or two support component so that or many of the one or more extension Individual part forms induction element, and described induction element can be by the silk centralized positioning at the center through described support means.

9. heart valve support part as claimed in claim 1, wherein bridge member and/or support component are equipped with heart tissue Anchoring devices, it is suitable to securely described support component be anchored to heart wall.

10. heart valve support part as claimed in claim 1, in farther including one or more ventricle and/or in atrium Stabilisation element.

11. heart valve support parts as claimed in claim 10, wherein stabilisation element is from by complete ring structure, part The group that ring, the arm of bending or wing and elongated arm or wing are constituted selects.

12. heart valve support parts as claimed in claim 1, the periphery of at least one of which support component is straight by least one The section that footpath reduces is interrupted.

13. heart valve support parts as claimed in claim 1, at least one of which support component farther includes heart valve week Potted component, described heart valve week potted component be the surface being attached at least one support component described in one edge The form of fabric curtain.

14. heart valve support parts as claimed in claim 1, including only two bridge members.

15. 1 kinds are suitable to Ink vessel transfusing and put or put to change mitral system through the apex of the heart, including: according to aforementioned claim In any of the one of heart valve support part；With the cardiac valve changed, it includes expansible anchoring piece and is suitable to be consolidated Surely multiple leaflets of described heart valve support part are arrived.

16. systems as claimed in claim 15, the cardiac valve wherein changed is prosthetic aortic valve's film.