CN104507418B - The keeper of prosthetic heart valve - Google Patents

Abstract

The prosthetic heart valve keeper of improvement and stocking system, it is isolated in advance or shrinks the bond post of valve in advance, to prevent thread entanglement.Isolation in advance and in advance contraction mean when manufacturing so that valve stores in the case of bond post is isolated and/or shrinks.This keeper can have entity lower limb, and this entity lower limb directly contacts and shrink and remain engaged with post, and do not use may be with the tension suture storing time creep.This keeper can have contact and flow into matrix and the shaft portion of end, and this shaft portion is prominent through leaflet and coordinates the moveable leg contacting bond post on valve outflow end.This keeper can have the flexible leg component extending through valve alternatively and have the distal portions being configured to extend across and isolate commissure post tip.

Description

The keeper of prosthetic heart valve

Related application

The application requires the U.S. Provisional Application sequence number 61/ submitted on July 31st, 2012 according to 35U.S.C. § 119 (e) The priority of the U.S. Provisional Application sequence number 61/779,890 that on March 13rd, 677,940 and 2013 submits to.

Invention field

The present invention relates to by isolating in advance and/or shrinking the promotion prosthese that valve bond post carries out keeping and storing in advance The keeper (holders) of cardiac valve implantation and method.

Background of invention

Valvular heart disease is morbidity and dead major reason, causes multiple disease, including rheumatic fever and birth defect. Native heart valve is considered as aorta, Bicuspid valve (mitral or bicuspid), Tricuspid valve and lung valve, and has respectively There is blade, to control the blood directed flow through heart.Worldwide, about 300 are carried out every year, 000 cardiac valve Replacement operation, and these patients accept bioprosthesis cardiac valve replacement to the most only about half of, and this bioprosthesis cardiac valve is put The tissue of biogenetic derivation of changing commanders intercepts blade for flexible fluid.

Heart valve prosthesis is that mechanical type used ball and cage originally, recently uses rotating machinery Guan Bi or group Knit type or " bioprosthesis " valve typically constructs by natural tissues leaflet.The most successful bioprosthesis material of flexible blade Material is full pig valve and is formed the independent blade of three-leaflet valve by being stitched together of making of bovine pericardium.But, have also been proposed by The flexible blade that polymeric material, fiber reinforcement shaped material and other synthetic materials are formed.The most frequently used flexible blade valve structure Make and include being installed on three blades of peripheral support structure and the bond post prominent along downstream or outflow direction.Blade has freedom Edge, is between bond post, flows central authorities in flowing and converges or engage, to allow one-way flow.Flowing into the suture around end can The suture ring penetrated generally provides the platform of grappling suture.

Prosthetic valve typically has a delivery keeper being positioned at center and sewing up with it, and be coupled to keeper, for The delivery handle of the elongation of valve assembly is handled during implanting.About standard delivery method, keeper is connected to inflow side Such as mitral suture ring, and outflow side such as support point or the outflow commissure tips of aortic valve.

When flexible blade prosthetic valve is arranged in Bicuspid valve or Tricuspid valve position, bond post is during delivering and implanting It is in valve to guide on side or blind side, and surgeon utilizes the handle of keeper and connection, valve is sliding along the array of suture Dynamic (landing), this suture mitral annulus the most around is installed in advance, then passes through valve stitching ring.Mitral valve position makes tool Have the outflow end of bond post during implanting its towards left ventricle advance time be leading end, therefore keeper is connected to the inflow of valve (that is, tail) is held.The difficulty delivering work makes the matter worse due to the narrow and small access lane of left atrium.Thread entanglement (looping) Sometimes one or more accidentally around in one or more in commissure post tip in the suture in landing array Occur when portion is wound around.If this situation occurs, the suture (one or more) of winding can slow down implant procedure, damages when fastening Badly in tissue blade, or interference lobe membrane operations and the joint to greatest extent of obstruction leaflet, cause prosthetic mitral valve defect. These problems can inter-operably solve, if surgeon knows thread entanglement, but owing to environment-development life is in Bicuspid valve or tricuspid The blind side of lobe, surgeon may be unaware that suture circle.If surgeon is not removed suture circle and is made the valve of implantation at leaf Leave the suture of winding on sheet, be then likely to result in blade tear, may be forced to carry out emergency operation.If occurred in tear After, incorrect diagnosis and result are fatal possibly for valve receiver.

On market, existing Bicuspid valve keeper attempts to reduce by post is moved (after contraction) towards valve central shaft The thread entanglement probability of bond post during implantation.Such as, U.S. Patent number 4,865,600 to Carpentier etc., it is provided that There is the keeper of following mechanism: sunset is to contract bond post before implantation.Carpentier device provides elongate stem to plant Enter period holding valve/valve holder combination, and cause bond post to contract.Closer to the phase, U.S. Patent number 6,409, 758,6,702,852,6,964,682,6,966,925 and 7,033,390 cardiac valve disclosing opposing thread entanglement keep Device system.

The bioprosthesis cardiac valve being configured to implant aorta or pulmonary artery position also may benefit from bond post contraction. I.e., although keeper is connected to valve outflow side, but the bottom radial contour of bond post is easy to implant, as cut by aorta Art.

Bioprosthesis cardiac valve be normally encapsulated in the cover of full listerine with operating room use before shipment with Store.Glutaraldehyde is widely used as storage solutions due to its antibacterial character.Due to glutaraldehyde be fixative or cross-linking agent and Fixation procedure is carried out, and bioprosthetic valve is stored in cover, and wherein its blade is in Guan Bi or bonding station and bond post Relax and do not shrink.This is present to ensure that blade is fixed as its shape being considered to have when Guan Bi.Otherwise, blade can present torsion Curved shape, this can negatively affect function, such as reflux after implantation.Therefore, the prior-art devices of joint is shunk in operating room In, valve implant shortly before activated.Multiple design is obtainable, and each of which is required to certainty action (affirmative action), this produces following risk: operating room technician shrinks bond post the most completely, may cause seam Line is wound around.This device is sometimes for some accurate steps, and it is chaotic that this possible patient bypasses in the pressure environment of operation on heart , and make problem more complicated.

Although existing substantial amounts of progress, this area needs remain for the holding helping prevent thread entanglement and more intuitively use Device and the relevant encapsulation of tectotype prosthetic mitral valve.

Summary of the invention

The application provides the keeper of prosthetic heart valve and relevant package system, and it more intuitively uses and shrinks in advance And/or isolate the bond post of valve in advance, to prevent thread entanglement and to be easily implantable.Shrink in advance and isolation means in system in advance When making so that valve shrinks at bond post and/or stores at least 24 hours in the case of isolation.Valve can be bioprosthesis, And stored dry persistently cross-links avoiding blade.End-blocking glutaraldehyde makes cross-linking process terminate, by consuming whole amine, disappearing Except aldehyde crosslink sites.In some embodiments, keeper has entity lower limb, and it directly contacts, shrinks and remain engaged with post, and Not using the suture of tension, this suture can the creep with the time of storage.

About aortic valve, keeper can have entity hinge and lower limb on valve outflow end, and it maintains bond post inside. About Bicuspid valve, keeper can have contact and flow into the matrix of end and shaft portion, this shaft portion prominent through leaflet and with connect Touch the moveable leg on the valve outflow end of zygostyle to coordinate.Disclosing such method, it includes shrinking valve bond post, so After valve is encapsulated in sterile chamber.

Application also describes the embodiment of the valve holder of such prosthetic heart valve: at native heart valve During implanting prosthetic heart valve at anchor ring, isolate commissure post tip, to prevent thread entanglement and to be easy to implant, without pulling Or the most radially inner contraction bond post.Keeper can have contact prosthetic valve and flow into matrix and the axle portion of end Point, this shaft portion is prominent through leaflet and coordinates the flexure member on prosthetic valve outflow end to isolate the end of bond post. Disclose such method: include isolating valve bond post, be then encapsulated in sterile chamber together with valve holder by valve.

In a representative embodiments, the valve holder of prosthetic heart valve includes the lower limb at multiple angled interval Component, it is configured to extend through prosthetic valve at least in part along outflow direction.Leg member has far-end isolated part, and And can move between position at radial outward position with radially-inwardly, wherein when leg member is in radial outward position, far-end Part extends in the commissure post tip of prosthetic valve and isolates the commissure post tip of prosthetic valve, and wherein works as leg member Be in radially-inwardly position time, distal portions is radially-inwardly spaced (spaced radially inward from commissure tips Of the commisure tips), and (withdrawn) can be retracted along towards the direction flowing into end through prosthetic valve.

In another representative embodiments, prosthetic heart valve assembly includes that prosthetic heart valve and valve keep Device.Prosthetic heart valve has inflow end, outflow end and multiple bond post, and this bond post terminates at along flowing out the end that direction is prominent End.Valve holder includes inside subject component and outside insulating element.Outside insulating element includes multiple angled interval Flexible leg component, each flexible leg component has the proximal part extending through prosthetic valve and the end being arranged in re-spective engagement post Distal portions on end.Inside subject component includes axle, this axle extend through leg member and maintain leg member be in radially to External position, wherein distal portions covers the end of bond post.Axle is removed from leg member along the direction flowing into end towards prosthetic valve Leg member is bent to radially-inwardly position, so that leg member is worn along towards the direction flowing into end away from commissure post tip Cross prosthetic valve to retract.

In another representative embodiments, the method implanting prosthetic heart valve includes providing prosthetic heart valve to assemble Body, it includes prosthetic heart valve and valve holder.Prosthetic valve has inflow end, outflow end and multiple bond post, and this connects Zygostyle terminates at along flowing out the end that direction is prominent.Valve holder includes inside subject component and outside insulating element.Outside Insulating element includes that the flexible leg component at multiple angled interval, each flexible leg component have and extends through the near of prosthetic valve End portion and the distal portions being arranged on the end of re-spective engagement post.Inside subject component includes axle, and this axle extends through lower limb Component and maintain leg member to be in radial outward position, wherein distal portions covers the end of bond post.Method is wrapped further Include delivery with fixed fae body valve in the natural valve anchor ring of heart, recall inside subject structure by the inflow end of prosthetic valve Part, causes leg member to be bent radially inward, and away from bond post, then recalls insulating element by the inflow end of prosthetic valve.

In another representative embodiments, the method for encapsulation prosthetic heart valve includes providing prosthetic heart valve, its Having inflow end, outflow end and multiple bond post, this bond post terminates at along flowing out the end that direction is prominent；Structure is isolated with providing Part, it includes that multiple flexible leg component, each flexible leg component have distal portions.Leg member is inserted the inflow of prosthetic valve End, until distal portions is in the far-end of the end of bond post, then makes the radially outer bending of leg member or deflection so that remote End portion covers the end of bond post.Then prosthetic heart valve and insulating element can be packaged to store and/or ship.

Accompanying drawing explanation

Along with being more fully understood that with reference to description, claims and accompanying drawing, it will be recognized that inventive feature and advantage.

Figure 1A is the plan view from above of the prosthetic heart valve from outflow end viewing, and showing of its application is fixed in display Example assembles the part of valve holder.

Figure 1B is the sectional view of the straight line 1B-1B intercepting along Figure 1A, and example extends through cardiac valve and has the heart The valve holder of the moveable leg that the bond post of dirty valve radially-inwardly shrinks, and Fig. 1 C is to intercept to regard from the amplification of Figure 1B Figure, the upper end of display valve holder.

Fig. 2 A-2C is the sectional view such as Figure 1B, shows and separates from prosthetic heart valve and remove the some of valve holder Step.

Fig. 3 A and 3B example are optionally with the locked cock (locking of the exemplary heart valve keeper in the application plug)。

Fig. 4 A and 4B assembles with prosthetic heart valve respectively, the bowing of the optional shrinkage type valve holder of the application Planar view and side elevation view, be preferred for aorta or pulmonary artery is implanted.

Fig. 5 is the perspective view of prosthetic heart valve, is depicted in during prosthetic valve is implanted around prosthetic valve bond post end The suture that end is wound around.

Fig. 6 is the perspective view of prosthetic heart valve assembly exemplary, assembling, that isolate in advance, this prosthetic heart Valve assembly includes valve holder, and this valve holder extends through prosthetic heart valve and has insulating element, its Middle distal portions extends in commissure tips and isolates commissure tips.

Fig. 7 be Fig. 6 exemplary, assemble, the side perspective view of prosthetic heart valve assembly isolated in advance, its The main shaft of middle delivery utensil is connected to the inflow end of valve holder.

Fig. 8 be part disassemble Fig. 6 under state exemplary, isolate in advance, prosthetic heart valve assembly saturating View, wherein distal portions is in radially-inwardly position, and interior shaft portion recall so that the fin (tab) on interior axle connects Touch the substrate ring of insulating element.

Fig. 9 is exemplary, the prosthetic heart lobe isolated in advance departing from Fig. 6 that the state of disassembling of prosthetic valve shows The perspective view of film assembly.

Figure 10 is exemplary, the decomposition diagram of prosthetic heart valve assembly isolated in advance of Fig. 6.

Figure 11 A is the perspective view of exemplary insulating element, and wherein distal portions is in lax shape radially-inwardly position.

Figure 11 B is the perspective view of the exemplary insulating element of Figure 11 A, and wherein distal portions is in radial outward position.

Figure 12 is that the side of the optional embodiment disassembling the prosthetic heart valve assembly isolated in advance under state is saturating View.

Figure 13 is the side perspective view of the valve holder of assembly shown in Figure 12.

Figure 14 is the perspective view of another embodiment of the prosthetic heart valve assembly isolated in advance under assembled state, The isolated part of suture contact assembly is implanted in display.

Detailed description of the invention

The present invention provides encapsulation, stores and deliver prosthetic heart valve to reduce the improvement of the complication during valve delivery System and method.Prosthetic heart valve can include the blade being usually bioprosthesis of flexibility, and this blade is at stream Engaging in dynamic stream and supported by peripheral branch shelf structure, this peripheral branch shelf structure includes vertical bond post.As it is well known in the art The neighboring independence of blade or in whole xenograft valve, be fixed in peripheral branch shelf structure, around this Supporting structure includes along the upright bond post flowing out direction cantilever.Bond post can bend after the implantation to a certain degree to adapt to stream The power of body dynamics.The bending of bond post assists flexible blade in reasonable time Guan Bi and to open, and simulates each heart The effect of the natural joint of valve anchor ring.But, owing to bond post axially extends along flowing out direction, it is in valve delivery extremely Have problems during target implantation site.

This application describes such system and method: shrink vertical bond post in advance, so that it is cured at surgery Teacher delivers valve to being bent radially inward during target implantation site and presenting smaller radial to profile.Application also describes so System and method: for isolating the end of vertical bond post during delivering in advance, without shrinking bond post.The prosthese heart Dirty valve assembly can include keeper and multiple flexure member, and this flexure member extends through prosthetic valve and has far-end Part, this distal portions extends on the end of bond post and isolates the end of bond post.Term " in advance shrink " and " in advance Shrink " mean to shrink bond post before operating room technician opens aseptic packaging.Equally, term " is isolated " and " pre-in advance First isolate " mean to isolate the end of bond post before operating room technician opens aseptic packaging.In other words, prosthetic heart Valve and shrink in advance and/or isolate the keeper of bond post in advance and be rendered as assembled state when leaving packaging, substantially accurate It is ready for being connected to deliver handle and deliver (after washing away any listerine, as needed).

The application can be used for the prosthetic heart valve with the bond post of any implantation site, but is used especially for Bicuspid valve And aortic valve.Additionally, This application describes be used especially for store during need not the dry prosthetic devices heart that liquid includes The technology of dirty valve.However, it is contemplated that the application is applicable to " wet " prosthetic heart valve, if taken preventive measures to make The long term storage of the valve that bond post shrinks is not result in leaf curling.For example, it is contemplated that synthesis blade can have one day quilt Success uses, and this synthesis blade is not fixed or cross-linked, and therefore can store by hygrometric state.Alternatively, bond post shrink, be completely fixed And the bioprosthesis blade not affected by long term storage can benefit from principle discussed herein.In brief, prosthetic heart lobe The type of film or blade is not construed as limited, unless respective right requires clearly to state.

Referring now to Figure 1A and 1B, display prosthetic heart valve 20 is assembled in the valve holder 22 of the application.Cardiac valve 20 include arrival end 24 and the port of export 26 separated along the vertical current moving axis through valve central authorities.The framework assembly that fabric covers Or support frame 28 limits periphery and the flow orifice of valve, and including bond post 30, this bond post 30 is along flowing out direction substantially On axially highlight, and bent along inflow direction arch point 32 separate.Three flexible blades 34 are coupled to framework 28, and And extend internally from it.Blade 34 connects along the heave line following bond post 30 and point 32.The transparent suture ring of suture 36 encloses Around the inflow end of valve 20, and can have shown planar perimeter shape or the most upwards rise and fall short distance at three bond posts 30 Shape.

Should be understood that term inflow/entrance and outflow/outlet mean that blood passes the flow direction of valve 20, it is shown Orientation is upwards.Additionally, due to the valve 20 of example is implanted at mitral annulus, there is going out of prominent bond post 30 Mouthful end 26 constitute deliver during the leading end of valve or far-end, and arrival end 24 is tail end or near-end.Therefore, at least at Fig. 1-2 Cardiac valve 20 and keeper 22 assembly in the case of, about direction, term arrival end and near-end are synonyms, and term goes out Mouth end and far-end are also.

As it has been described above, prosthetic heart valve 20 and other prosthetic heart valves described herein can include multiple having joint The existing cardiac valve of post 28, and the specific configuration that cardiac valve is in addition to having bond post is not qualified as the pass of the application Key section.But, as explained below, the bioprosthesis cardiac valve of stored dry is particularly suited for the keeper with the disclosure and skill Art is integrated.

It is known for being dried and storing bioprosthesis cardiac valve and be not dipped in the technology of listerine.Term is " dry Dry " or " being dried " bioprosthesis cardiac valve simply mean in the case of without listerine, store those valvular energy Power, and term " is dried " and is not construed as and fragility or rigidity synonym.It is true that " being dried " bioprosthesis heart valve leaflet can be very To being the most all flexible relative.Have pointed out multiple method generally for being dried bioprosthesis cardiac valve and dry group Knitting implant, the application considers to use by any one valve processed in these methods.Particularly preferred dry bioprosthesis Valvular method is disclosed the U.S. Patent Publication No. 2008/0102439 of Tian etc..Optional drying means is disclosed U.S. Patent number 6,534,004 in Chen etc..Reiterating, these and other valvular methods of dry bioprosthesis can Use before implementing storing technology described herein.

A kind of such strategy is to make bioprosthetic tissue be dehydrated in glycerol/alcohol mixture, sterilizes with oxirane, End product with encapsulation " being dried ".This process eliminates glutaraldehyde as antibacterial and the genotoxic potential of storage solutions and calcification Effect.If have pointed out drying method utilize sugar alcohol (that is, glycerol), alcohol, and combinations thereof as rear glutaraldehyde processing method so that gained Tissue is in " being dried " state, rather than has the moisture state of excessive glutaraldehyde.Method based on glycerol can be used for this storage, As (Thorax 1978 33:638) such as Parker describes.Equally, U.S. Patent number 6,534,004 (Chen etc.) describe biology Prosthetic devices is at polyhydric alcohol such as the storage in glycerol.During making to be organized in ethanol/glycerite dehydration, ring can be passed through Tissue is sterilized by oxidative ethane (ETO), gamma-radiation or electron beam irradiation.

Closer to the phase, Dove etc. is proposed in dehydrated tissue in U.S. Patent Publication No. 2009/0164005 can be due to oxygen The solution of some undesirable change changed and occur.Dove etc. propose the aldehyde radical (reductive amination) in permanent end-blocking tissue.Dove Etc. also describing, activating agent (such as, antioxidant) is added dehydrating solution (such as, ethanol/glycerol), to prevent (the epoxy that sterilizes Ethane, gamma-radiation, electron beam irradiation etc.) and store during tissue oxidizing.The group processed according to disclosed principles such as Dove Knit and will be named as " tissue of end-blocking ", therefore, use the cardiac valve of this tissue will be named as " the tissue flap of end-blocking Film ".End-blocking glutaraldehyde, by consuming whole amine, the crosslink sites of elimination aldehyde, makes cross-linking process terminate, and thinks that this works in coordination with By stored dry, tissue valve prosthesis is removed crosslinker solution (such as, glutaraldehyde), be the mode of maximally effective termination cross-linking process.

As Figure 1B is visible, valve holder 22 extends through cardiac valve 20, and has moveable leg 40, and this may move Lower limb 40 makes valvular bond post 30 radially-inwardly shrink.More specifically, valve holder 22 includes relatively wide matrix part Dividing 42, it contacts with the inflow end 24 of cardiac valve 20；With the shaft portion 44 of axial elongation, it is from body portion distally Extend through cardiac valve.Shaft portion 44 highlights along central shaft, and far-end crosses valvular blade 34.Moveable leg 40 It is arranged, rotates, as described below with the top around shaft portion 44.There are three moveable leg 40, corresponding to three valves Each in bond post 30.

Each having outer end in moveable leg 40, this outer end has brachydactylia 46, and this brachydactylia 46 is at each bond post 30 Outside on downwardly extend.As visible in Fig. 1 C, the inner of each lower limb 40 is respectively provided with pivot and bar structure, makes locked cock 48 activate lower limb 40. More specifically, the upper end of keeper shaft portion 44 is included on its inwall the ladder 50 formed.Propping up in each moveable leg 40 Point projection 52 is seated on ladder 50, and bar projection 54 extends radially inwardly from it.In the exemplary embodiment, locked cock 48 wraps Including major diameter bottom 60 and minor diameter top 62, it produces flange 64, and this flange 64 receives the bar projection 54 of moveable leg 40, as Shown in Fig. 1 C.Bar projection 54 is connected to the upper end of locked cock 48 by frenulum 66.The wire drawing 68 being connected to locked cock 48 lower end allows to use Locked cock is proximally moved by person.

Prosthetic heart valve 20 He of the assembling that Figure 1A and 1B exemplary manufacturer provides in aseptic pig or packaging Keeper 22.In this configuration, valve bond post 30 by inside tractive and is kept the moveable leg 40 of device 22 and fixes.By Outflow end in Figure 1A is visible, and blade 34 is slightly rolled so that it engages free edge 35 and is found at keeper shaft portion 44 Outer periphery.After making bond post 30 be bent outwardly to its POF, vane free edge 35 connects from each with SANYE configuration Zygostyle generally diametrically extends internally to central shaft (not shown).As it has been described above, prosthetic heart valve 20 is preferably dried storage, Wherein can store in the case of no liquid preservative for the bioprosthetic tissue of blade 34 is treated.So, blade 34 Fully fixed, and the crosslinking occurred in listerine is not occurred.Therefore, though blade 34 during storing relative to it Functional configurations slightly deforms, and as Figure 1A is visible, it also will recover its suitable functional configurations after removing keeper 22.

Should be understood that the keeper 22 with the lower limb 40 shrinking bond post 30 keeps being in suitably during Bicuspid valve 20 delivers Position, until suture ring 36 is seated mitral annulus.Only during delivering downwards the array of preassembled grappling suture, Bond post 30 is needed to shrink.In time manufacturing, start bond post 30 curve inwardly and the degree that keeps is somewhat dependent upon use Material in the support frame 28 that fabric covers.That is, the material stress limit of support frame 28 (or assembly therein) determines to connect Zygostyle 30 can Long-term bend and holding maximum in angle.Exceeding this limiting range of stress, some materials include for building Valvular metal will occur plasticity or permanent deformation.Polymeric material is being pressed onto more than this material characteristic point and storage Creep can occur when depositing temperature, cause permanent deformation and the inefficacy after implanting may be caused.In one embodiment, bond post 30 are presented under its lax shape function configuration and are in angle slightly inward, and are kept device 20 further and curve inwardly and protect Hold extra 15-30 °.Such as, for average-size valve, this conversion is about extra the curving inwardly between 4-5mm Distance, the absolute distance of the least valve is smaller, and vice versa.Reiterating, Perspective of organization deformation is depended on by carriage The material stress limit of frame 28 controls, desired radial direction delivers profile.

Fig. 2 A-2C be such as Figure 1B in sectional view, display after target annulus is located cardiac valve occur from prosthese Cardiac valve 20 separates and removes some steps of valve holder 22.Fig. 2 A display wire drawing 68 and the proximal displacement of locked cock 48. By connecting frenulum 66, such movement the most proximally pulls the bar projection 54 on moveable arm 40.Fulcrum projection 52 is protected Ladder 50 on holder shaft portion 44 inside, and cause moveable arm 40 inwardly to rotate, as shown.This makes the finger 46 of arm 40 from each Bond post 30 discharges, and each bond post the most outwards bounces to its lax shape POF.

Fig. 2 B display wire drawing 68 and the further proximal displacement of locked cock 48, moveable arm 40 is also drawn together and passes by this The inner chamber 45 of keeper shaft portion 44.Therefore the movable part of keeper 22 can be made to remove completely from implantation site, it is possible to logical Cross tubular handle 70.Handle 70 is connected to the proximal hub 72 on keeper 22, and can be flexible such that it is able to pass through non-thread The access way of property.

Finally, Fig. 2 C example removes whole keeper 22 from prosthetic heart valve 20.In a preferred embodiment, need not Suture connects keeper 22 and valve 20, and the latter is simply maintained between the arm 40 of keeper and body portion 42, such as Figure 1B. Alternatively, although do not show, connect suture and can be arranged through the neighboring of body portion 42 and through valve stitching ring 36. By the two ends of each connection suture being connected to keeper 22, and provide and can be able to lead in the cut point of central cutout suture or hole Cross simple cut-out and connect suture, remove each connection suture in company with keeper.

Fig. 3 A and 3B example are used for the optional locked cock of the exemplary heart valve keeper of the application.

The contraction in advance of the application that Fig. 4 A and 4B example optionally fit together with prosthese aortic heart valve 82 Valve holder 80.As it has been described above, during aortic heart valve delivers, flowing into end is leading end or far-end, and has The outflow end of its bond post is tail end or near-end.So, valve holder 80 is coupled to outflow end or the bond post 84 of valve 82 End.As in the past, prosthetic valve 82 farther includes support frame, and it limits three vertical bond posts 84, and these three are erected Straight bond post 84 and three arch points 86 are alternately.Right side fabric cover 88 is removed, to expose exemplary support case framework Make.Specifically, support frame includes wire rod 90, usually metal；With support 92, usually polymer.Valve support frame Various internal structures be known in the art, the embodiment of example should not be regarded as limiting.

Valve holder 80 includes central hub 94, and this central hub 94 has can connect the chamber delivering handle (not shown) 96.Three lower limbs 98 in each bond post 84 outer periphery at a certain angle outwards and downwardly extend, and directly contact bond post 84, Thus remain engaged with inside converging angles θ of post.Angle, θ takes from the straight line through the bond post 84 being in lax shape function configuration, It is offset slightly from the angle [alpha] of vertical about 5 °, as shown.In one embodiment, make bond post 84 to inflection by keeper 20 Bent and keep about 15-30 °, this depends on being controlled by the material stress limit of support frame again, desired radial direction delivers Profile.

In one embodiment, the lower limb 98 of keeper 80 utilizes suture or the similar means that can easily remove to be fixed in The end of bond post 84.Alternatively, lower limb 98 can have and can protect during valve stores and is delivered to target implantation site The important document recalled holding the end of bond post 84 but can quickly discharge, such as little barb (barbs).Further, available connect Zygostyle 84 and the band around lower limb 98 or or together with tether (not shown) retains the assembly in, until when release valve.

Keeper 80, and the most outward extending lower limb 98, should be by storing at a temperature of valve under at constant load not The material of notable creep is made.Metal material, including rustless steel, cobalt chromium (CoCr) or titanium, will be preferred, but some polymer Also it is acceptable, as long as improvement in creep resistance is not result in that bond post 84 is the most mobile during storing.Such as, some high temperature polymerizations Thing, such as Polyetherimide, can be suitable.Additionally, usable fibers adds strength polymer, to prevent creep.Alternatively, keeper Can be designed with high inertia area moment (area moment of inertia), therefore strain is minimized, to reduce creep. The stress level on material, temperature and material is depended in creep, and therefore, thickness portion opposing is from the load of stent strut Strain level can be reduced.

Fig. 5 shows exemplary prosthetic heart valves 100 and describes how suture can be wound around on the bond post of valve.Prosthese Cardiac valve 100 includes inflow end, outflow end, blade 102, flows into the suture ring 104 at end and highlight and whole along flowing out direction Terminate in three bond posts 106 of end 108.Isolation and/or the post of end is there is not during the delivery of prosthetic heart valve 100 In the case of the contraction of 106, can be hooked in the commissure tips 108 of one of them bond post 106 one or many of suture 110 On individual, as shown in Figure 5.

Fig. 6-10 shows prosthetic heart valve assembly 112, and it includes prosthetic heart valve 100 and valve holder 114 according to another embodiment.Such as the embodiment of Fig. 1-4, this embodiment and other embodiments described herein The prosthetic heart valve 100 of middle use can include any number of existing prosthetic valve with bond post 106, and this prosthese Valve specific configuration in addition to having bond post is not qualified as the key component of the application.

Valve holder 114 is configured to isolate commissure post tip 108, thus prevents from being delivered to natural lobe at prosthetic valve Thread entanglement during film anchor ring.In a specific embodiment, valve holder 114 is without shrinking bond post 106, but at valve Isolate commissure post tip between delivery period, and bond post can keep the functional status that is in its non-deflection.In example embodiment Valve holder 114 includes inside subject component 116 and the outside isolation being arranged in around inside subject component with assembled state Component 118.Inside subject component 116 in example arrangement include matrix 120 and from matrix 120 extend substantially cylindrical Interior axle 122.Interior axle 122 can include elastic fin 124 (seeing Fig. 8-10), and its purpose is described below.In example arrangement every From component 118 include matrix or substrate ring 126, the central opening 128 (seeing Figure 10,11A-B) limited by substrate ring 126 and The multiple leg members 130 extended from substrate ring 126.

Such as Figure 11 A-11B best image, each leg member 130 has respective near-end body portion 132 and is connected to Substrate ring 126, respective distal portions 134 and respective mid portion 136 prolong between body portion and distal portions Stretch.Insulating element 118 has and the leg member 130 of prosthetic valve bond post 106 equal number ideally.Therefore, example is implemented Mode has three such leg members 130, although greater or lesser number of leg member can be provided.Axle 122 can be formed many The groove 138 being circumferentially spaced of individual longitudinal extension, this groove 138 is configured to when assembly is in assembled state (such as Fig. 6 institute Show) receive each leg member 130 at least in part.Leg member 130 ideally around substrate ring 126 by essentially homogeneously every Open, with the mapping bond post 106 circle spacing around prosthetic valve 100.

Leg member 130 is normally biased to present radially-inwardly position (Figure 11 A), and can be bent outwardly (flex or Bend) to radial outward position (Figure 11 B).Therefore, in the case of putting on leg member 130 without any power, it presents Figure 11 A Shown inward position；This is referred to alternatively as the relaxed state of leg member.But, when the axle 122 of inside subject component 120 is inserted into Through the opening 128 of substrate ring 128 and when inserting leg member 130, leg member 130 is caused to be deflected outward by so that distal portion Divide 134 location to isolate commissure tips 108 (Fig. 6), as described further below.On the contrary, by axle 122 from leg member 130 it Between space remove so that leg member bending or spring back to radially-inwardly position.By this way, leg member 130 is referred to alternatively as hanging Arm spring.

The radial thickness of distal portions 134 can be more than the near-end of leg member 130 and the radial thickness of mid portion.Specifically Embodiment in, distal portions 134 includes curve convex distal surface 152, its back to (facing away from) engage Place end 108, and be suitable to extend (extent) cross and isolate commissure tips.The mid portion 136 of leg member can be relative It is thinner than distal portions 134 and body portion 132, is beneficial to leg member in inflection point (Figure 11 B) and non-deflected posi-tion (Figure 11 A) Between deflection.

For with the valve of mode assembled prosthesis shown in Fig. 6 100 and valve holder 114, insulating element 118 being inserted through vacation Body valve 100 (with blade 102), until distal portions 134 extends across commissure post tip 108 and substrate ring 126 is adjacent or Adjoin the suture ring 104 of prosthetic valve.Then, the interior axle 122 of inside subject component 116 is insertable through central opening 128 He Insert between leg member 130 so that leg member 130 each groove 138 on axle 122 aligns.Axle 122 is forced through lower limb structure Part 130, to advance radial outward position by leg member and distal portions 134 thereof so that distal portions 134 extends across and isolates The end 108 of bond post 106.As seen in figs. 8-10, the outer surface of interior axle 122 can have elastic fin 124, this elastic fin 124 project radially outwardly from the outer surface of axle.Fin 124 is shaped, to allow fin 124 that axle 122 is being inserted insulating element When 118 below substrate ring 126 process, and engage substrate ring 126 and prevent axle 122 and insulating element 118 from moving in opposite direction Separate during axle.Therefore, along with axle 122 is inserted through substrate ring 126 and inserts between leg member 130, substrate ring 126 can contact Tilting or tilting outermost surfaces of fin 124, order about fin curve inwardly and make the fully-inserted leg member of axle 122 130 it Between (Fig. 6).When fin 124 is through substrate ring 126, fin 124 is bend radially outward or springs back to its relaxed state.

Fig. 7 is the side perspective view of the prosthetic heart valve assembly 100 under assembled state, the layout of display suture 140, This suture 140 makes the matrix 120 of inside subject component 116 be fixed on the substrate ring 126 of insulating element 118.As shown, matrix 120 Near-end (inflow) surface 146 can include multiple groove 142 radially extended.Each suture 140 is through respective groove bridging, and has Having two ends, this end extends through matrix 120 and substrate ring 126 along flowing out direction.Each suture 140 through substrate ring The end of 126 can be tied on together, as shown at 144, thus temporarily makes inside subject component 116 be fixed on insulating element 118.Matrix 120 and the substrate ring 126 of inside subject component can have suture hole, it is allowed to suture 140 is during assembly through that A little assemblies.The engageable commissure tips of distal portions 134 108 of leg member 130 so that prosthetic valve 100 maintains isolation structure Appropriate location around part 118.In alternative embodiments, identical or other suture can make matrix 120 and/or matrix Ring 126 is fixed on the inflow end of prosthetic valve 100, such as, by making suture pass the suture ring 104 of prosthetic valve 100.Prosthese Valve 100 can be introduced into patient body with the assembled state shown in Fig. 6 and 7, and be delivered to desired implant site and (adjoin two points Lobe).In the assembled state, the bond post 106 of prosthetic valve 100 is without curving inwardly or deflecting, and can be at the merit of non-deflection Energy position is to be delivered in health, as shown.

The proximal end face 146 of the matrix 120 of inside subject component 116 can include screwed hole or the opening being positioned at center, its The distal portions for the manually axle 148 delivering utensil of delivery prosthetic heart valve assembly 100 can be received.Axle 148 near End may connect to the handle that the person of being adapted in use to handles.In other embodiments, inside subject component 116 can have other connection machines Structure, to connect the axle delivering utensil.The present invention is about delivering utensil, handle or the type of relevant device or about the company delivering utensil Connect type not to be restricted.After user has connected delivery utensil, prosthetic heart valve assembly 100 can be delivered and be fixed on The natural valve anchor ring of heart, such as mitral annulus.

Fig. 6 shows prosthetic valve 100 and the keeper 114 of manufacturer's offer in aseptic pig or packaging.Deliver The axle of utensil can be pre-attached to keeper 114, and is packaged together with prosthetic valve and keeper.At other embodiments In, the axle delivering utensil can individually encapsulate, and can be installed on valve holder by user sunset before surgery.As it has been described above, Prosthetic valve 100 can have the tissue blade of " being dried ", and can be in the case of without listerine together with valve holder Store.So, any distortion of the blade 102 caused by valve holder during storing will not make blade permanent deformation, and one Denier removes from valve holder, and this blade can present its normal function shape.

Although the most convenient for user, it should be noted that prosthetic valve 100 and valve holder 114 can be sealed Be contained in single sterile chamber or packaging in, under hoc scenario, user can before surgery sunset with above-mentioned form by valve prostheses Film is installed on valve holder.Such as, valve holder 114 can be additionally used in and is implanted in listerine the prosthetic valve stored. For the permanent deformable blade avoiding cross-linking process to cause, it may be desired to by valve holder 114 and the vacation stored in listerine Body valve individually encapsulates.

In natural valve anchor ring, user, suture array can be fixed on natural lobe with fixed fae body valve 100 for delivering Film anchor ring, makes suture pass the suture ring 104 of prosthetic valve 100, and along suture slip prosthetic valve assembly 100, until false Body valve 100 is located against natural valve anchor ring, as known in the art.As it has been described above, thread entanglement can occur at landing array In suture in one or more one or more inner periphery being wrapped in accidentally in commissure post tip.Distal portion 134 are divided to extend across commissure post tip, to prevent thread entanglement.When along suture array landing prosthetic valve, bending far-end Surface 152 can contact suture and suture is pushed away commissure post tip.

Prosthetic heart valve assembly is disassembled in Fig. 8-9 display after prosthetic valve being fixed on safely natural valve anchor ring 100 and recall the process of valve holder 114 from prosthetic valve 100.First, matrix 120 is made mechanically to depart from substrate ring 126 With the most suitable prosthetic heart valve 100, such as, pass through suture 140 shown in shearogram 7.Then, as shown in Figure 8, will Its axle 148 that may connect to deliver utensil of inside subject component 116 withdraws prosthese along proximal direction shown in arrow 150 Valve 100.In in this stage, axle 122 recalls the outward radial force removed leg member 130 so that distal portions 134 is to connecing The internal bending of zygostyle 106, thus expose commissure tips 108.At this moment or in retracting further after axle 122, fin 124 connects Touch and engage substrate ring 126.From now on, along with inside subject component 116 is recalled the most further, fin 124 Insulating element 118 is caused to withdraw prosthetic valve 100 together with inside subject component 116.It is in its lax footpath at distal portions 134 In the case of inside state, insulating element 118 may pass through blade 102 and is withdrawn, and complete together with inside subject component 116 Full removal prosthetic valve 100, as shown in Figure 9.

Although interior axle 122 is cylindrical and central opening 128 is circular in example embodiment, but Nei Zhouhe center Opening can have other shapes.Such as, interior axle 122 can have non-circular cross-section facial contour and (is being perpendicular to the plane of its length In), and central opening 128 can be non-circular shape, it can be the shape identical or different with interior axle cross-sectional profiles. And, interior axle 122 can have the cross-sectional profiles of change along its length, such as axle 210 (Figure 12-13 are described below) in taper. In a particular embodiment, the distal portions 134 of leg member can contact commissure post tip 108, although optional embodiment party In formula, leg member may be configured such that and can there is small-gap suture between commissure post tip 108 and distal portions 134.

Inside subject component 116 and insulating element 118 can be made up, including metal of any number of in various suitable materials Or any number of, as various in metal alloy (such as, titanium, rustless steel, Nitinol, cochrome) or various polymeric material Polyamide, polyester or copolyesters.Can be used for being formed some realities of the polymer of inside subject component 116 and/or insulating element 118 Example includes without limitation, polyethylene terephthalate (PET), politef (PTFE) or polyoxyethylene methylene (POM).In fortune In the embodiment made, insulating element 118 is made of titanium, and inside subject component 116 is made up of suitable polymer.

In alternative embodiments, different technology and/or mechanism can be used for making leg member 130 in inwardly or outwardly position Bend between putting or mobile.Such as, axle 122 in replacing, one or more bars or connector can be operationally coupled to each lower limb Component 130, to cause leg member to move between inwardly or outwardly position.The handle delivering utensil can include switch or actuator, It is coupled to leg member operably by one or more bars or connector, thus activates switch or actuator effectively causes Leg member 130 moves.

The optional embodiment of the prosthetic heart valve assembly 200 under Figure 12 display part partition solution state, it includes vacation Systemic heart valve 100 and valve holder 202.Figure 13 shows the valve holder 202 separated with prosthetic valve 100.Such as Figure 12 Shown in 13, the valve holder 202 in example embodiment includes inside subject component 204 and outside insulating element 206.In Portion's main component 204 can include matrix 208 and from the prominent interior axle 210 of matrix 208.Interior axle 210 can be along axle far-end to matrix The direction of 208 is taper so that the diameter of distal portions 212 more than the axle proximal part of premature 208.Matrix 208 can It is connected to deliver the distal portions of the axle 224 of utensil.Insulating element 206 can include substrate ring 214, and it limits central opening 216； With multiple leg members 218, it is connected to and extends from substrate ring 214.Leg member 218 can have the distal portions 220 of wedge shape, its It is configured to during prosthetic valve 100 delivers extend across and isolate commissure post tip 108, such as the reality above for Fig. 6-11 Execute described in mode.

For being arranged in by insulating element 206 around the diminished shaft 210 of inside subject component 204, substrate ring 214 can be formed Slit or gap 222.By this way, substrate ring 214 has open loop (split-ring) configuration, it is allowed to substrate ring 214 is opened Open and be arranged in around interior axle 210, as shown in figure 13.In a particular embodiment, axle in the internal diameter of ring 214 is slightly larger than The external diameter of the proximal part of 210 premature 208.In alternative embodiments, substrate ring 214 need not have open-loop configuration, But inside subject component and insulating element can be mould, machining or otherwise with assembled state shape, wherein every It is previously placed at around axle 210 from component.

For assembled prosthesis valve 100 and valve holder 202, axle 210 is maintained at part relative to insulating element 206 and removes The position returned, so that distal portions 220 keeps non-deflected state (as shown in Figures 12 and 13).At insulating element and inside subject structure In the case of part is in this position, leg member 218 can be inserted through prosthetic valve 100 (with blade 102), until distal portions 220 distally being in commissure post tip 108.Once substrate ring 214 adjoins the inflow end of prosthetic valve 100, and distal portions 220 will It is in commissure post tip 108 distally, but still is radially-inwardly spaced from commissure post tip 108.Then, interior axle 210 can by towards Distal portions 220 promotes, and causes the bend radially outward position crossing commissure post tip 108 to distal portions 220 of leg member 218 Put.The distal portions 212 of axle 210 in taper can be made to bend or mellow and full, such as Fig. 6-10, to contribute to along with axle 210 is worn by promotion Cross insulating element and leg member 220 is pushed into radial outward position.After assembling, valve holder 202 and prosthetic valve 100 can one Rise and be encapsulated in sterile chamber or packaging (with or without axle 224).

For after prosthetic valve has been sutured in natural valve anchor ring by valve holder 202 and prosthetic heart valve 100 It is disengaged, cuts off connecting the matrix 208 suture (not shown) with substrate ring 214, so that inside subject component 204 and isolation structure Part 206 is disengaged.Then, delivery utensil is utilized to recall inside subject component 204.Along with interior axle 210 is contracted, from interior axle The power pushing leg member 218 to of the distal portions of 210 is removed.Then, distal portions 220 can be withdrawn into radially-inwardly position Put, thus expose commissure post tip 108.Along with axle 210 is further retracted, the outer surface of axle 210 is at axle certain position Contact substrate ring 214, the external diameter at this position axle 210 approximates the internal diameter of the central opening 216 of substrate ring 214.With this side Formula, recalling further of axle 210 effectively makes insulating element 206 pass and recall away from prosthetic valve.

Figure 14 shows the optional embodiment of prosthetic valve assembly 300, and it includes that prosthetic heart valve 100 and valve are protected Holder 302.Valve holder 302 in example embodiment includes matrix 304, the interior axle 306 extended from matrix 304 and connects It is connected to the delivery utensil axle 308 of the matrix side contrary with interior axle 306.Valve holder 302 can further include at interior axle 306 weeks Enclose multiple far-end isolated parts 310 at interval.Far-end isolated part 310 can be at least partially recessed into interior axle in the first state In each the groove (not shown) radially extended formed in 324, can project radially outwardly from groove in the second condition.

More specifically, during prosthetic valve 100 and valve holder 302 assemble, far-end isolated part 310 can maintain In each groove and/or inside axle so that isolated part 310 is radially-inwardly spaced from commissure post tip 108.In this position, interior Axle 306 and isolated part 310 can be through prosthetic valve 100 (with blade 102) and push the outflow end of prosthetic valve to.Work as isolation part When dividing 310 to be forced past commissure post tip, may result in isolated part 310 and project radially outwardly from groove, extend across and isolate Commissure post tip, as shown in figure 14.Various technology and/or mechanism can be used for causing isolated part 310 from groove outwardly.One In individual detailed description of the invention, such as, isolated part 310 can be loaded spring and/or can be by extend through the connection group of axle 308 Dress body or the actuator that is operably connected on handle of bar or switch.Activate actuator or switch causes insulating element 310 certainly Interior axle 310 protrudes outwards to the position shown in Figure 14.

Prosthetic valve 100 can be delivered and be sutured in the natural valve anchor ring of heart in the above described manner, utilizes valve Keeper 302, by sliding along the suture array being fixed on natural anchor ring or landing prosthetic valve 100.Figure 14 shows suture 314, it contacts the far-end of one of them isolated part 310.Along with prosthetic valve is pushed to natural anchor ring, isolated part 310 pushes away Move or guiding suture 314 is away from bond post 106, to prevent suture to be wound around around neighbouring commissure post tip 108.Once valve prostheses Film 100 is fixed in natural valve anchor ring, and the switch/actuator delivered on the handle of utensil can be activated, with by isolated part 310 Radially-inwardly it is retracted in groove and/or interior axle 306 is internal so that isolated part is radially-inwardly spaced from commissure post tip, so Rear valve holder can be through prosthetic valve 100 and recalls and retract from health.

In a particular embodiment, the keeper of the present invention includes such component: it is configured to isolation and/or footpath To contract bond post, without the suture using tension.The suture of tension shrinks when being used in operation in the past and engages Post, but owing to the tendency of its creep in time may be unsuitable for long term storage.If employing suture and it entering when storing Having gone creep and stretching, bond post can finally be bent outwardly, and therefore loses intended purpose.In terms of time frame, before this All it is designed to activate after removing from aseptic packaging and when operation for isolating or shrink the mechanism of valve bond post.By In good surgical practice problem, by surgical implant after aseptic packaging removes, it should relatively quickly be implanted or abandoned To prevent from polluting.Therefore, to be defined to purpose, implementations described herein wherein prosthetic valve and keeper assembly It is pre-assembled, wherein makes bond post shrink by the part of keeper and/or then isolation stores and use in the future Meaning the storage through at least 24 hours, to get rid of before this, those are designed the mechanism to activate when operation.

Although the present invention is described in its preferred implementation, it is to be understood that the term used is to describe to use Language rather than words of limitation.Therefore, can be changed within the scope of the appended claims, and without departing from the actual model of the present invention Enclose.

Claims (17)

1. the valve holder of prosthetic heart valve, described prosthetic heart valve has inflow end, outflow end and multiple bond post, Described bond post terminates at along flowing out the end that direction is prominent, and described valve holder includes:

The leg member at multiple angled intervals, it is configured to extend at least partially through described prosthese along described outflow direction Cardiac valve, described leg member has distal portions and can move between position at radial outward position with radially-inwardly, its In when described leg member is in described radial outward position, described distal portions extends across and isolates the institute of described bond post State end, and wherein when radially-inwardly position described in described leg member is in, described distal portions is from described bond post Described end is radially-inwardly spaced, and can be contracted along towards the direction of described inflow end through described prosthetic heart valve Return.

2. the valve holder described in claim 1, wherein said leg member is biased by being radially oriented inside part, and institute Stating valve holder and farther include interior axle, described interior axle is configured to extend through described leg member and described prosthetic heart lobe Film, thus described leg member is pushed into described radial outward position, and wherein said interior axle removing in described leg member Described leg member is caused to move to described radially-inwardly position.

3. the valve holder described in claim 1, wherein said leg member includes cantilever spring, and described cantilever spring is by normally Biasing, with radially-inwardly position described in presenting, and described valve holder farther includes the inside subject component that can be removed, Described inside subject component can be inserted into the space between described leg member so that described leg member be maintained at described radial direction to External position, wherein said distal portions covers the end of described bond post.

4. the valve holder described in claim 1, the radial thickness of the described distal portions of the most each leg member is more than described The proximal part extending through described prosthetic heart valve of leg member.

5. the valve holder described in claim 1, the described distal portions of the most each leg member includes that being suitable to isolate each connects The curve convex distal surface of end at conjunction.

6. the valve holder described in claim 1, wherein said leg member includes respective proximal part, described proximal part Being connected to substrate ring, described substrate ring is configured to the inflow end of adjacent described prosthetic heart valve.

7. prosthetic heart valve assembly, including:

Prosthetic heart valve, it has inflow end, outflow end and multiple bond post, and described bond post terminates at and dashes forward along flowing out direction The end gone out；With

Valve holder, it includes that inside subject component and outside insulating element, described outside insulating element include multiple angulation The flexible leg component at degree interval, each flexible leg component has proximal part and the layout extending through described prosthetic heart valve Distal portions on the end of re-spective engagement post, described inside subject component includes that axle, described axle extend through described lower limb structure Part and maintain described leg member to be in radial outward position, wherein said distal portions covers the end of described bond post, and And wherein remove described axle from described leg member cause described lower limb structure along the direction flowing into end towards described prosthetic heart valve Part bends to radially-inwardly position, away from the end of described bond post, so that described leg member is along the side towards described inflow end It is contracted to through described prosthetic heart valve.

8. the prosthetic heart valve assembly described in claim 7, wherein said prosthetic heart valve includes bioprosthesis blade, And described assembly is accommodated in aseptic packaging with drying regime.

9. the prosthetic heart valve assembly described in claim 7, the radial thickness of wherein said distal portions is more than described lower limb The described proximal part of component.

10. the prosthetic heart valve assembly described in claim 7, wherein said insulating element includes substrate ring, described matrix Ring adjoins the inflow end of described prosthetic heart valve, and described leg member is connected to described substrate ring and from described matrix hoop institute The outflow end stating prosthetic heart valve extends, and described axle includes that radially projecting fin, described fin are configured at described axle Along towards described prosthetic heart valve flow into end direction move time engage described substrate ring and cause described insulating element from Described prosthetic heart valve is recalled.

Prosthetic heart valve assembly described in 11. claim 7, wherein said insulating element includes substrate ring, described matrix Ring adjoins the inflow end of described prosthetic heart valve, and described leg member is connected to described substrate ring and from described matrix hoop institute State prosthetic heart valve outflow end extend, described inside subject component include near-end body portion, described axle be connected to and Extending from described body portion, described body portion adjoins the described substrate ring of described insulating element and is releasably attached to The inflow end of described prosthetic heart valve.

Prosthetic heart valve assembly described in 12. claim 11, the described body portion of wherein said inside subject component It is sutured in the inflow end of described prosthetic heart valve.

Prosthetic heart valve assembly described in 13. claim 7, wherein said bond post is in the POF of non-deflection.

Prosthetic heart valve assembly described in 14. claim 7, wherein said valve holder includes handle and main shaft, described Main shaft has the proximal part being connected to described handle and the distal portions being connected to described inside subject component.

The method of 15. encapsulation prosthetic heart valves, including:

Thering is provided prosthetic heart valve, it has inflow end, outflow end and multiple bond post, and described bond post terminates at along outflow side To prominent end；

Thering is provided insulating element, it includes that multiple flexible leg component, each flexible leg component have distal portions；

Described leg member is inserted the inflow end of described prosthetic heart valve, until described distal portions is in described bond post The distally of end；

Bend radially outward described leg member so that described distal portions covers the end of described bond post；With

Encapsulate described prosthetic heart valve and described insulating element, to store and/or shipment.

Method described in 16. claim 15, wherein said prosthetic heart valve includes tissue blade, and by the described prosthese heart Dirty valve and described insulating element store with drying regime.

Method described in 17. claim 15, wherein bends described leg member and includes being coaxially inserted into inside subject component wearing Crossing described insulating element, described inside subject component causes described leg member bend radially outward.