CN101711139A - Prosthetic heart valve - Google Patents
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- CN101711139A CN101711139A CN200880017531A CN200880017531A CN101711139A CN 101711139 A CN101711139 A CN 101711139A CN 200880017531 A CN200880017531 A CN 200880017531A CN 200880017531 A CN200880017531 A CN 200880017531A CN 101711139 A CN101711139 A CN 101711139A
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Abstract
The present invention includes prosthetic heart valves having flexible leaflets and methods for fabricating the valves which improve upon the prior art.
Description
Priority
The title that the application requires to submit on May 25th, 2007 is the U.S. Patent application No.11/754 of " Cardiac valve prosthesis (Prosthetic Heart Valve) ", and 250 priority is incorporated the content of its disclosure into this paper with way of reference and is used for whole purposes.
Technical field
The present invention relates to have the Cardiac valve prosthesis of the flexible lobule of making by tissue or synthetic material, also relate to the improved method of making such valve.
Background technology
Human heart has four principal valves of direction of flow of blood in the control circulation.Aortic valve and Bicuspid valve are the parts of " left side " heart, control rich oxygen containing blood and flow to health from lung, and valve of pulmonary trunk and Tricuspid valve are the parts of " right side " heart, and the blood that control exhausts oxygen flow to lung from health.Aortic valve and valve of pulmonary trunk are positioned between pumping chamber's (ventricle) and the aorta, prevent that blood from draining back to ventricle injected after going into circulation.Bicuspid valve and Tricuspid valve are positioned between receiving chamber (atrium) and the ventricle, prevent that blood from draining back in the atrium between injection period.
Cardiac valve can show abnormal anatomical structures and function owing to congenital or posteriori valve disease.The congenital valve deformity can be restrained oneself develops into life-threatening problem for many years and only in the gerontal patient, perhaps can be seriously to the degree that just needs emergency operation in initial several hours of morbidity.Hypertension also can cause the cardiac valve deformity.Valve disease will comprise degenerative disease (for example, Barlow's disease, fibrous elasticity tissue lack), inflammatory diseases (for example, rheumatic heart disease) and infectious disease (for example, endocarditis) day after tomorrow.In addition, can make the geometry variation of valve, cause its dysfunction by previous heart attack (that is, being secondary to the myocardial infarction of coronary heart disease) or other heart diseases (for example, cardiomyopathy) ventricle damage that causes.
Because cardiac valve is in response to the passive structure that the pressure reduction of particular valve both sides is only open and close, therefore, the problem of following valve and displaying can be divided into two classes: (1) is narrow, wherein valve is not correctly opened, and (2) incomplete (being also referred to as anti-stream), wherein valve is not correctly closed.Valvular stenosis is present in when not opening the relative obstruction that causes blood flow fully owing to valve.Valvular regurgitation is present in owing to valve is not closed when causing blood to drain back to previous chamber fully.Narrow and the existence of can in same valve or different valve, not accompanying entirely.Both of these case all increases the workload of heart and is unusual serious situation.The seriousness that this pressure to heart and patient increases, and heart adapts to its ability has determined unusual valve whether to need operating substitution or has repaired in some cases.If do not obtain handling, these situations will cause weak symptom, comprise congestive heart failure, permanent heart and injury and final death.
Handicapped valve can be repaired, and keeps patient's self valve, or is replaced by certain type machinery or biovalve substitute.Because all artificial valve have some shortcomings (for example, need handle all the life with blood thinners, form the risk of grumeleuse and limited service life), therefore under possible situation, valve repair is preferable over valve replacement usually.Yet the ill degree of many handicapped valves has exceeded the limit of repairing.
The dysfunction of left side valve (aortic valve and Bicuspid valve) is more serious usually, because left ventricle is the main pumping chamber of heart.Aortic valve is more prone to narrow, and is that it is normally caused by the calcification material on lobe leaf accumulation and need aortic valve replacement usually.The aortic valve that refluxes can be repaired sometimes, but is normally replaced.In modern society, modal Bicuspid valve condition of illness relate to since always the springing up of lobule (gross billowing of leaflets) to less relatively chordae tendineae extends and ischemic diseases causes backflow.In the great majority of these situations, the leaflet of mitral valve soft pliable can long term maintenance in multiple repair process.Yet at the center of third world countries' neutralization from the high mobility of third world countries, modal condition of illness or disease are the rheumatic mitral valve diseases.The tendon with remarkable distortion (chord) of this generation thicken, unpliant lobule or chordae tendineae (chordae tendinae) be often with the fusion of two lobules.The rheumatic valve is unsuitable for the repair process of any kind, so it is almost always replaced.
Because the demand on the right side of heart significantly less than the left side, is therefore related to valve of pulmonary trunk and tricuspid dysfunction is uncommon.Valve of pulmonary trunk has the 26S Proteasome Structure and Function of the aortic valve of being similar to.Almost always the congenital heart defect with complexity is relevant for the dysfunction of valve of pulmonary trunk.Sometimes in having the adult of congenital heart disease all the year round, implement the valve of pulmonary trunk displacement.Tricuspid anatomical structure and function and Bicuspid valve are similar.It also has lobe ring (annulus), chordae tendineae (chords) and papillary muscles, but has three lobules (frontal lobe, posterior lobe and every leaf).The shape of lobe ring is slightly different, and volute is bigger and slightly asymmetric.
Cardiac valve prosthesis can be used to replace any cardiac valve.The heart valve prosthesis of two kinds of main types is known.A kind of is the mechanical type cardiac valve, and mechanical closure that its utilization articulates or ball and cage design are to provide unidirectional blood flow.Another kind is " bio-artificial " valve, it is very similar to the valvular lobule of the natural mankind by the lobule structure made from natural tissues and its mode with the natural action of imitation heart valve leaflet and plays a role, for example, they seal each other or Colaesce between the adjacent tissue that is called Colaesce (commissure) connects.The structure of different sort of man worker valve has the structure of the bioprosthetic valves of being similar to, but its lobule is made by flexible synthetic material.
Every type artificial valve has the merits and demerits of himself.At present, mechanical valve prosthesis has the longest service life of available replacement heart valve.Yet the implantation of mechanical valve prosthesis needs the receptor to take anticoagulant in accordance with regulations in case the hemostasis piece forms.The lasting use of anticoagulant may be dangerous, because it has greatly increased the risk of user generation severe haemorrhage.In addition, mechanical valve prosthesis can be heard sound usually for the receptor, and can not have omen ground to lose efficacy, and it can cause serious consequence, even dead.
On the contrary, the artificial valve with bioprosthetic valve and/or synthetic lobule is flexible and noiseless, and those adopt the valve of natural tissues lobule not need to use blood thinners.Yet chien shih lobule sclerosis at any time of naturally occurring process or calcification especially at the region of high stress of valve, are located as the Colaesce junction between the lobe leaf with at outer peripheral peripheral lobule attachment point place or " tip " of each lobule in the human body.In addition, valve bears the stress that ex vivo continues machine operation.Especially, lobule is in tensioning state in make position, and is in compressive state at open position.Therefore, the artificial valve of these types is worn and torn in time and is needed and changes.Bioprosthetic valve is compared with mechanical heart valve with synthetic lobule cardiac valve, makes much more difficultly, and the cost more time is because they are by being made by handwork substantially with skilled personnel through specialized training.
Bioprosthetic valves comprises: homograft valve, and it comprises fully the valve of collecting from human donor or corpse; The allograft valve, biomaterial that is provided by the human corpse is provided for it; From body homology valve, biomaterial that is provided by the individuality of accepting valve is provided for it; And xenograft valve, it comprises the biomaterial that obtains from non-human organism source (comprising pig, cattle and other animals).
Present obtainable xenograft valve is to make up like this, be sewn onto wire frame/form or support (so that lobule is remained on the tram) by lobule with porcine aortic valve, or by pericardial cavity (it holds heart) structure lobe leaf from cattle, horse, pig or other animals, and they are sewn onto wire frame/form, and support rack or ring are arrived in wire frame/form Colaesce, and it is commonly called the pericardium valve.Example with commercial valve of a kind of configuration in back is Carpentier-Edwards Perimount
TMThe pericardium valve.The support of this valve has the upper surface with the lower surface " coupling " of line structure, and the edge clamping of lobule betwixt.Any for the xenograft valve embodiment of these types makes up wire frame/support and thinks that the lobe leaf provides the supporting structure of dimensionally stable, and it gives to a certain degree controlled flexibility to reduce the stress on valve-open and the down periods leaflet tissue.Described wire frame/support is coated with the biocompatibility fabric and (is generally polyester material, as Dacron
TMOr PTFE), it provides suture attachment points for lobule Colaesce and tip.Replacedly, the suture ring that covers of fabric can be attached to wire frame or support and sew up the attachment area of valve structure to be provided in operation valve replacement process in patient's heart tram.Many prosthetic tissue valves with these constructs are described in United States Patent (USP) the 4th, 106, and 129,4,501,030,4,647,283,4,648,881,4,885,005,5,002,566,5,928,281,6,102,944,6,214,054,6,547,827,6,585,766,6,936,067,6,945,997,7,097, No. 659 and 7,189,259 and U.S.'s publication application No. 2003/0226208 and No. 2006/0009842 in, its full content is incorporated herein with way of reference.
Though carried out improvement repeatedly in the past few decades, existing tissue valve prosthesis still has their shortcoming.Size and quality between the apparent surface that such shortcoming is line structure and support do not match.Not described not matching usually because the annular transmutability of support.The support of prior art is by the material of certain-length, and it is formed or circumflexion configuration and end are welded together.Described formation and welding process make support be easy to " resilience ", that is, ring can experience slight distortion in time and become so not round.Itself and line structure are being stitched together after-applied tension force on support, and the tension force that during the normal operation of valve, experiences, make support further be easy to resilience.As shown in Figure 1, do not match and 2 be present between round wire structure 4 and the so round support ring 6.This do not match 2 cause usually line structure 4 on either direction from support ring 6 skew that becomes, it causes the instability between the parts again.Described instability causes uneven stress point, especially on the lobe leaf, and causes valve wearing and tearing subsequently to be quickened.
Another shortcoming of the construct of existing bio-artificial tissue valve prosthesis is might form grumeleuse within the covering scope that places on line structure and the support ring.This can explain best with reference to Fig. 2, when it shows the natural agent that stands to be applied by lobule when Colaesce is positioned at make position, and the cross-sectional side view (line structure is not shown) at the bioprosthetic valves commissural points place of prior art.For line feeder structure-support assembling, Colaesce extension or supporter 8 are incorporated valve in the everywhere of its Colaesce usually.Supporter 8 is elongated outstanding, and it extends upward (towards the outflow opening of valve) and be located substantially between support ring 6 and the line structure (not shown) in the spatial dimension that the commissural points at valve forms from support ring 6.These Colaesce parts are made by relatively hard still flexible (bent) material usually, for example are called the acetate material of the sale of MYLAR with trade mark.Similarly, use the centripetal force (radially inward force) that is applied on the lobe leaf and under natural service condition, put on the tension force that forms on the valve commissures (as, the blood return pressure) after, described Colaesce part can be slightly towards inner bending, bending or inclination.When this tilts to take place, between fabric cover 5 and Colaesce holder 8, can form bag 7, wherein thrombosis can form the also mobile and valvular function of block blood.
Therefore, still there be performance and the space stable and that be used to improve the technology of making described valve that is used to improve tissue heart valve.The invention is intended to solve aforesaid drawbacks, keep simultaneously valve hope the 26S Proteasome Structure and Function characteristics and guarantee the functional lifetime of valve.
Summary of the invention
The present invention includes Cardiac valve prosthesis and the method that is used to make them.Described Cardiac valve prosthesis comprises supporting structure, line structure (wireform) and flexible lobe leaf.Described supporting structure comprises at the bottom of the cyclic group and the Colaesce extension that stretches out from described substrate on the outflow direction of valve.Described line structure is operably connected to supporting structure at its outflow end.Described lobule is formed by flexible biocompatible materials, comprises biological tissue, and after one's own heart package is knitted, and/or synthetic material, as polyurethane, or their combination.
Described valve is incorporated multiple improvement into to solve and to overcome the shortcoming of prior art tissue valve prosthesis.During these improve some have solved " not matching " problem that may reside between described line structure and the support.For example, in a kind of variant, the gauge of support (that is, the external diameter of support and the size between the internal diameter) is made into to be equal to or greater than the diameter dimension of line structure.In other variant, the size of the flux surface of supporting structure is greater than the size that flows into the surface.In some embodiments, the ratio of the inflow surface size of the flux surface size of support and support can for 1: 1 at least about 8: 5 or bigger.In another variant, the flux surface of support is provided with depression to hold the diameter dimension of line structure in tip portion.In addition, in other variant, described support forms by this way so that its structure is seamless and has keep constant diameter shape basically under the normal operation of valve.In addition, the line structure of described valve can have the diameter shape substantially the same with described supporting structure so that described line structure and supporting structure each interval constant distance, and constant (remaining unchanged) kept at this interval under the normal operation of valve thus.
Solved thrombotic problem in the obducent scope on line structure that places valve and support by other improvement more provided by the invention.Especially, wherein, owing to be applied to the power on the valve under the normal operation condition when inwardly straining, described improvement minimizes or prevents to form bag between the inner surface of Colaesce extension of covering part and support at extension.
In a kind of variant of artificial valve of the present invention, described supporting structure has aligned Colaesce extension in the Colaesce highest point of described line structure, wherein said extension is slight inwardly angled to limit the angle with the predetermined fixed of the inwall of support, usually from about 0 ° in about 10 ° scope.Like this, the scope that moves of Colaesce extension experience is minimized, and makes the minimizing possibility of the formation bag between covering part and cradle wall thus.The one-tenth angle of Colaesce extension can as sewing up, be connected to the support substrate with the Colaesce extension that forms respectively and realize that wherein their connection is defined as flexible joint mechanically.Replacedly, described extension can form with angle predetermined fixed or predetermined and support monoblock type.In both cases, the flexible junction point between support Colaesce and the support substrate allows Colaesce inside warpage or bending when bearing the normal operation power that is applied on valve and its lobule.In order to form bag between the inner surface that further prevents textile material and Colaesce extension, obducent setting flushes with inner surface basically.This can be by realizing sewing up between the two.
Method of the present invention comprises the manufacture of intraocular valve, and wherein supporting structure is molded as at least in part and has the shape of mating basically with the shape of line structure.Such method may further include from the molded Colaesce extension of identical mould as the support substrate to form overall structure.Other valve manufacture methods of the present invention comprise to form or to provide the Colaesce extension of support with the inwall angulation of support.In other embodiment, the Colaesce extension forms and subsequently to provide the mode of flexible joint to be connected to wherein between each Colaesce extension and support substrate respectively from the substrate of support.
From description with reference to the accompanying drawings, other features, purpose and the advantage of invention will become more apparent.
Description of drawings
When reading in conjunction with the accompanying drawings, from following detailed, the present invention will be understood best.Be stressed that according to conventional practice, the various features of accompanying drawing is not proportional.On the contrary, for clear, manifold size is subjectively enlarged or is dwindled.Also be that features more of the present invention are not drawn in some drawings for purpose clearly.Following figure comprises in the accompanying drawings:
Fig. 1 is the sketch map of the vertical view of bioprosthetic valves in the prior art, and wherein solid line is represented line structure, and dotted line is represented supporting structure;
Fig. 2 is the cross-sectional side view of prior art artificial valve's Colaesce extension in commissural points;
Fig. 3 A is the artificial valve's of the present invention line structure of assembling and the side view of supporting structure;
Fig. 3 B is the viewgraph of cross-section of the valve assemblies of Fig. 3 A along the line B-B of Fig. 3 A;
Fig. 3 C is the end-view of amplification of the cross section of the valve assemblies that limits of the circle C of Fig. 3 B;
Fig. 3 D is the viewgraph of cross-section of valve assemblies along the amplification of the line D-D of Fig. 3 B; And
Fig. 4 is the cross-sectional side view of substrate of the tip portion of valve assemblies of the present invention.
The specific embodiment
Now with reference to Fig. 3 A-Fig. 3 D and Fig. 4,, the present invention is described in more detail by description to the variant of following illustrative embodiment and new device, system and method.The present invention generally includes implantable Cardiac valve prosthesis 10, and described cardiac valve 10 has lobe ring support 12 and the line structure (wireform) or the framework 14 of loop type, and wherein said support has similar basically diameter with line structure.Described line structure has the arc cusp 14a and the axial Colaesce 14b of replaceable pattern, the quantity of the arc cusp 14a of each valve and axial Colaesce 14b is generally three thus, be intended to metathetical natural valvular 26S Proteasome Structure and Function so that the most closely mate it, as aortic valve (though three-leaflet valve of the present invention also is suitable for replacing the valve of two cusps, as Bicuspid valve).The natural profile of this corrugated pattern simulation appendices lobularis is used to the prosthetic leaflet (not shown) of supporting that valve is interior.Support 12 has the cusp part 12a and the Colaesce 12b of tight match pattern, and it is operatively coupled on a time-out at support and line structure and aims at (fraction 22 at the tip of described Colaesce is open or unoccupied) with the corresponding cusp 14a and the Colaesce 14b of line structure 14.End with valve 10 of Colaesce parts 12b, 14b limits the outflow end of valve, and the opposite end is for flowing into end.
As many conventional prosthetic tissue valves, before line structure 14 was operably connected to support 12, the line structure 14 (referring to Fig. 4) that has been covered by textile material 42 is at first used, installed and be fixed to tissue leaflets sub-component (not shown).The structure of bonded tissue-line structure is fixed to supporting structure 12 subsequently, and leaflet tissue edge 44 is clipped in wherein, to form the valve 10 of assembling.As shown in Figure 4, ring 12 also covers with textile material 42 respectively.Support and line structure stretch out forming outthrust 42a and 42b respectively from described parts radially, and the part of textile material provides and has been used for device 46 that two parts are stitched together.Be operably connected to a time-out, line structure 14 is positioned at support 12 tops, thus the top of line structure and support 12 or flux surface 34 is aimed at and through the top or the flux surface 34 of support 12.In the valve of assembling fully of the lobule sub-component with integration, the gap or the interval 20 that are defined between described two parts are occupied by the organization edge 44 of lobule on whole length in gap 20.As previously mentioned, described valve is configured to be directly fixed on natural valve ring (annulus) or can additionally be attached to the suture ring (not shown), and described suture ring is attached to the natural valve ring.
Manyly be used to form lobule, formation/sweep structure 14, make support 12 and install and be connected multiple parts and describe (it is incorporated into way of reference) in the patent document in front to together multiple technologies and material, they are well-known and are understood by those skilled in the art.For example, tissue leaflets can be downcut from the tissue of results, as bovine pericardium.The textile material that is used to cover line structure and support can be DACRON
TMOr other suitable textile materials.Line structure 14 can be made by the nickel cobalt (alloy) silk that is generally used for such line structure (being made by Elgiloy Ltd Partnership), and support 12 can be by metal or the machining or molded plastic material (for example, the DELRIN of machining
TM) make.
Adopting the supporting structure that the invention has the advantages that of molded support ring is seamless (being different from the joint that forms inevitably in welding support), the shape of support can be formed desirable shape more accurately, therefore, more accurately with the form fit of line structure.Similarly, along with shape is separately very closely mated, when valve bears the power that is applied thereto in valve manufacturing process, for example be stitched into a time-out, more greatly, heavier bracket component can not make weak, lighter line structure distortion at support and line structure.For example, do not mate so closely, when putting on stitching between the fabric that covers two parts too tightly or when tight inadequately, exist line structure with respect to ring 12 the outflow end surface 34 not middle tendency (referring to Fig. 4, it is placed in the middle equably with respect to the flux surface of described ring that line structure is shown) that becomes.This parts match guarantees that also line structure and support keep equably at interval each other, that is, the interval between them is kept constant about whole valve, distributes therebetween structural pressure thus equably.Valve on the whole and especially on the leaflet tissue power of uniform distribution be intended to make the valve risk minimization of wearing and tearing too early.
Another feature of the present invention is the flux surface 34 of support and the relative thickness of the diameter of line structure, it combines separately or with the shape of the tight coupling of support and thread structural elements, the auxiliary centralized positioning of keeping correct aligning and line structure with respect to the outflow end surface of support.Typically, conventional bioprosthetic valves has the line structure diameter of about 0.020 " to about 0.030 ", and the thickness of support is about 0.015 ".Follow these relative size, bearing when putting on the tension force that the natural power on the valve and the stitching that forms by line structure is fixed to support apply, the tendency of the flux surface 34 of line structure has outstanding (overhang) support by blood flow.This is given prominence to and can occur in inner support surface 30 or support arm surface 32.In order to address this problem, described valve bracket can have the outflow rack surface 34 that thickness is equal to or greater than the thickness of line structure diameter.For example, flux surface can have the thickness of scope from about 0.020 " to about 0.1 ".Similarly, " shoulder " is provided on the rack surface with any slip of holding the line structure on it or moves, and makes the easier realization of the centralized positioning of line structure on rack surface and can keeping.
Shown in Fig. 3 C, another optional feature of described valve bracket has provided depression or the groove 38 in the flux surface 34 of the cusp part of support.Described depression can have any suitable cross-sectional profiles, for example wedge shape, circle etc., and have the size of the size (or having the size of the radius of the line that fabric covers) of the diameter that is enough to hold described line, and for example, radius of curvature.
Those skilled in the art will recognize that and wish to keep wide as far as possible and do not comprise the function of valve and the valve orifice of stability.Similarly, consider valve of the present invention with respect to location (supra-annular positioning) on the lobe ring of natural valve ring, described valve provides thicker support flux surface, keeps simultaneously and the same width of blood stream access that passes through valve.This realizes that by selecting the support shape of cross section described shape is tapered to flowing into surface 36 from flux surface 34, that is, the flux surface 34 of support is greater than the corresponding inflow surface 36 of support.In the embodiment shown in Fig. 3 C, flux surface 34 is thicker than or greater than flowing into surface 36.In some variants, flow out with flow into surperficial ratio can from about 1: 1 at least about 8: 5, but can depend on enforcement and greater or lesser.In one embodiment, flux surface has about 0.040 " size or thickness, flow into the surface and have about 0.025 " size or thickness.
Except flowing out and flow into the relative size of rack surface, the given shape that can design the support cross section is to improve flowing dynamics.For example, the shape of cross section of the support ring of Fig. 3 C is roughly trapezoidal, and inner surface 30 is basically parallel to flow direction, and outer surface 32 is outwards angled to limit ledge (ledge) or the shoulder that extends towards natural lobe ring.Like this, held flux surface 34 increase thickness and do not reduce effective hole area.Though the embodiment that illustrates shows angled outer surface 32, can adopt the upright surface that is incorporated in the valve structure with other property held geometries.
The method relevant with described valve device also expected within the scope of the present invention.Described method can comprise manufacturing and/or installation step or activity, the bending, tissue apposition that includes but not limited to molded and/or machining, the line structure of support ring in line structure to form the lobe leaf, line structure and support to be stitched together etc.Additive method provide with body in the application and the application of implanting valve in relevant step and activity or the body in secret and the step and the activity of implantation of valve.
Another aspect of the present invention comprises the test kit with at least one valve of the present invention.Test kit can comprise and be used to prepare, send, the multiple miscellaneous part of implantation and secure valve.Described test kit can also comprise the written explanation of the implantation that is used for device.Such explanation can be printed in the substrate, as paper or plastics etc.Similarly, explanation can be in test kit exists as package insert, in the labelling of the container of test kit or its parts, exist, or as being stored in suitable computer-readable recording medium such as the electronic data file on CD-ROM, the USB etc. provides.
Preamble only shows principle of the present invention.Should understand, not describe clearly or illustrate, embody principle of the present invention and be included in the interior various configurations of its spirit and scope though those skilled in the art can design at this paper.In addition, all examples as herein described and conditional language mainly are intended to help reader understanding's principle of the present invention and the artificial design that develops this area and contribute of invention, and should be interpreted as being not limited to the such clearly example and the condition of statement.In addition, principle of the present invention as herein described, aspect and embodiment with and all narration intentions of specific embodiment comprise its 26S Proteasome Structure and Function equivalent.In addition, such equivalent is intended to comprise the equivalent of present known equivalent and following exploitation, that is, any element of the enforcement said function of being developed, no matter and its structure how.Therefore, scope of the present invention is not intended to be limited to the illustrative embodiments that this paper describes and illustrates.On the contrary, scope and spirit of the present invention are embodied by appended claim.
Must be noted that " one ", " a kind of " and " described " of singulative comprise plural object, unless context spells out other implications as used in this paper and the appended claim.Therefore, for example, can comprise a plurality of such cotton ropes, comprise with reference to " described tube-like piece " relating to one or more tube-like pieces and its equivalent well known by persons skilled in the art with reference to " cotton rope ", or the like.
Unless other implications pointed out clearly in context, when numerical range is provided, be interpreted as also having disclosed particularly the intervenient value between the upper and lower bound of this scope, each concrete value is accurate to 1/10th of lower limit unit.In any described value in the described scope or intervenient value and this described scope between any other described value or the intervenient value each includes in the present invention more among a small circle.These upper and lower bounds more among a small circle can be comprised in scope or be excluded, the present invention includes one of upper and lower bound of each scope, upper and lower bound all be not included in more among a small circle in or upper and lower bound include in more among a small circle, in described scope, accept the restriction of any concrete eliminating.When described scope comprises one or two boundary, get rid of and comprise that the scope of one or two boundary is also included within the present invention.
All publications that this paper mentions are merged in herein to disclose and to describe method and/or the material relevant with the publication that is cited with way of reference.The publication of this paper discussion is submitted to a few days ago by the disclosure that is provided for them individually in the application.The content of this paper can not be interpreted as admitting the present invention owing to formerly invent prior to such publication and can not be authorized to.In addition, the date of the publication that provides can be different from the actual publication date, and it may need to be confirmed separately.
Claims (13)
1. Cardiac valve prosthesis comprises:
Limit the line structure of most advanced and sophisticated and Colaesce;
Supporting structure, have substrate and a plurality of in the Colaesce of described line structure aligned Colaesce extension, wherein said Colaesce extension is slight inwardly angled to limit the angle with the inwall of described support substrate.
2. Cardiac valve prosthesis according to claim 1, wherein said angle from about 0 ° in about 10 ° scope.
3. Cardiac valve prosthesis according to claim 1, wherein the crossing qualification between each described Colaesce extension and the described support substrate has the flexible junction point of the moving range between about 0 ° to about 45 °.
4. Cardiac valve prosthesis according to claim 3, wherein said moving range is between about 2 ° to about 5 °.
5. Cardiac valve prosthesis according to claim 4, wherein said Colaesce extension are the parts that form respectively, and wherein they form mechanically to the junction point separately of described support substrate.
6. Cardiac valve prosthesis according to claim 5, wherein said mechanical system comprises stitching.
7. Cardiac valve prosthesis according to claim 3, wherein said Colaesce extension and described support substrate are whole to be formed, and each junction point limits by hinges.
8. Cardiac valve prosthesis according to claim 1 further comprises:
At least cover the textile material of the inner surface of each Colaesce extension, wherein said textile material flushes basically with the inner surface of described Colaesce extension.
9. Cardiac valve prosthesis according to claim 8 is wherein sewed up and is kept described fabric cover and flush basically with the described inner surface of each Colaesce extension.
10. Cardiac valve prosthesis according to claim 1, wherein said Colaesce extension comprises Mylar.
11. comprising, a method that is used to make the described artificial valve of claim 1, described method provide the described Colaesce extension that becomes the angle of predetermined fixed with the described inwall of described support substrate.
12. method according to claim 11, wherein the step of Xing Chenging comprises the molded overall structure that comprises described support substrate and described Colaesce extension.
13. method according to claim 11, wherein the step of Xing Chenging comprises described Colaesce extension is connected to described support substrate.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US11/754,250 US20080294247A1 (en) | 2007-05-25 | 2007-05-25 | Prosthetic Heart Valve |
US11/754,250 | 2007-05-25 | ||
PCT/US2008/064660 WO2008147960A1 (en) | 2007-05-25 | 2008-05-23 | Prosthetic heart valve |
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CN101711139A true CN101711139A (en) | 2010-05-19 |
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Application Number | Title | Priority Date | Filing Date |
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CN200880017531A Pending CN101711139A (en) | 2007-05-25 | 2008-05-23 | Prosthetic heart valve |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102652694A (en) * | 2012-05-24 | 2012-09-05 | 上海欣吉特生物科技有限公司 | Prosthetic heart valve |
WO2013173997A1 (en) * | 2012-05-24 | 2013-11-28 | 上海欣吉特生物科技有限公司 | Artificial heart valve |
CN110913803A (en) * | 2017-06-05 | 2020-03-24 | 爱德华兹生命科学公司 | Mechanically expandable heart valve |
-
2008
- 2008-05-23 CN CN200880017531A patent/CN101711139A/en active Pending
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102652694A (en) * | 2012-05-24 | 2012-09-05 | 上海欣吉特生物科技有限公司 | Prosthetic heart valve |
WO2013173997A1 (en) * | 2012-05-24 | 2013-11-28 | 上海欣吉特生物科技有限公司 | Artificial heart valve |
CN102652694B (en) * | 2012-05-24 | 2014-06-25 | 上海欣吉特生物科技有限公司 | Prosthetic heart valve |
US9474600B2 (en) | 2012-05-24 | 2016-10-25 | Shanghai Cingular Biotech Corporation | Prosthetic heart valve |
CN110913803A (en) * | 2017-06-05 | 2020-03-24 | 爱德华兹生命科学公司 | Mechanically expandable heart valve |
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